AzTrials
AzTrials

Lung CancerPhase 3NCT00533949

High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

A Phase 3 study testing Cetuximab, Carboplatin and Paclitaxel in people with Lung Cancer and Radiation Toxicity, run by Radiation Therapy Oncology Group at 213 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Radiation Toxicity
What is being tested?
Cetuximab, Carboplatin and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
544 participants
Where
213 sitesin 2 countries
Study dates
Nov 2007to 20 May 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC); excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, [according to American Joint Committee on Cancer (AJCC) Staging, 6th edition; see appendix III] within 12 weeks of registration; patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor also are eligible.
  • Patients must be considered unresectable or inoperable; Note: Patients who have had a nodal recurrence after surgery for an early-stage NSCLC are eligible if the following criteria are met:
  • Nodal recurrence must be N1 or N2; N3 is not eligible.
  • The initial primary must have been staged as T1-2, N0, M0.
  • The node must be biopsied within 12 weeks of registration.
  • The node must be measurable.
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  • The patient must not have received prior chemotherapy or radiation for this lung cancer.
  • Prior curative surgery must have been at least 6 months prior to the nodal recurrence.
  • The exception to a prior invasive malignancy does not apply to the initial lung primary.
  • Stage III A or B disease, including no distant metastases, based upon the following minimum diagnostic workup are acceptable:
  • History/physical examination, including documentation of height, weight, body surface area (BSA), and vital signs within 8 weeks prior to registration;
  • Computed tomographic (CT)/Magnetic Resonance Imaging (MRI) imaging of the lung and upper abdomen through the adrenal glands within 6 weeks prior to registration;
  • An MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 6 weeks prior to registration; Note: The use of intravenous contrast is required for the MRI or CT. An MRI without contrast is only permitted if the patient has a contrast allergy.
  • Whole-body fluorodeoxyglucose (FDG) - Positron Emission Tomography(PET) or PET/CT or if no PET is available, a bone scan is required within 6 weeks prior to registration; Note: If a PET is done that shows clear adrenals and lungs, then a CT scan of chest only is permitted.
  • If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (incurable T4 disease):
  • When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
  • Exudative pleural effusions are excluded, regardless of cytology;
  • Effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible.
  • Patients must have measurable or evaluable disease.
  • Patients with post-obstructive pneumonia are eligible.
  • Patients must be at least 3 weeks from prior thoracotomy (if performed).
  • Zubrod Performance Status 0-1;
  • Age ≥ 18;
  • Pulmonary function tests (PFTs) including forced expiratory volume in one second (FEV1) within 12 weeks prior to registration; for FEV1, the best value obtained pre- or post bronchodilator must be ≥ 1.2 liters/second or ≥ 50% predicted.
  • Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;
  • Platelets ≥ 100,000 cells/mm3;
  • Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable.)
  • Serum creatinine within normal institutional limits or creatinine clearance ≥60 ml/min;
  • Bilirubin must be within or below normal institutional limits;
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2.5 x the institutional upper limit of normal (IULN);
  • Patient must sign study specific informed consent prior to study entry.

Who cannot join

  • N3 supraclavicular disease;
  • Greater than minimal, exudative, or cytologically positive pleural effusions;
  • Involved contralateral hilar nodes (i.e. greater than 1.5 cm on short axis or positive on PET scan);
  • ≥ 10% weight loss within the past month;
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible.
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
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  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
  • Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway;
  • Prior severe infusion reaction to a monoclonal antibody;
  • Severe, active co-morbidity, defined as follows:
  • Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
  • Transmural myocardial infarction within the last 6 months;
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration;
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  • Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin;
  • Uncontrolled neuropathy grade 2 or greater regardless of cause.

Trial locations and contacts

213 sites in 2 countries.

213 sites in 2 countries

United States207 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • New York Oncology Hematology, PC at Albany Regional Cancer Care

    Albany, New York, 12206

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Tulane Cancer Center Office of Clinical Research

    Alexandria, Louisiana, 71315-3198

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • Theda Care Cancer Institute

    Appleton, Wisconsin, 54911

  • Texas Oncology, PA at Texas Cancer Center - Arlington South

    Arlington, Texas, 76014

  • Georgia Cancer Center for Excellence at Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Emory Crawford Long Hospital

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Texas Oncology, PA at Harris Center HEB

    Bedford, Texas, 76022

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Alamance Cancer Center at Alamance Regional Medical Center

    Burlington, North Carolina, 27216

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Sands Cancer Center

    Canandaigua, New York, 14424

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Mercy Cancer Center at Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Enloe Cancer Center at Enloe Medical Center

    Chico, California, 95926

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters

    City of Saint Peters, Missouri, 63376

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, 94524-4110

  • Payson Center for Cancer Care at Concord Hospital

    Concord, New Hampshire, 03301

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Texas Oncology, PA at Texas Cancer Center - Denton South

    Denton, Texas, 76210

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Dale and Frances Hughes Cancer Center at Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Shore Regional Cancer Center at Memorial Hospital - Easton

    Easton, Maryland, 21601

  • Midelfort Clinic - Luther

    Eau Claire, Wisconsin, 54703-1510

  • Luther Midlelfort Hospital

    Eau Claire, Wisconsin, 54703

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Regional Cancer Center - Erie

    Erie, Pennsylvania, 16505

  • Willamette Valley Cancer Center - Eugene

    Eugene, Oregon, 97401

  • Center for Cancer Care at Exeter Hospital

    Exeter, New Hampshire, 03833

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • Poudre Valley Radiation Oncology

    Fort Collins, Colorado, 80528

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Radiation Oncology Associates Southwest

    Fort Wayne, Indiana, 46804

  • Parkview Regional Cancer Center at Parkview Health

    Fort Wayne, Indiana, 46805

  • Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital

    Fort Worth, Texas, 76104

  • Saint Agnes Cancer Center at Saint Agnes Medical Center

    Fresno, California, 93720

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Center for Cancer Care at Goshen General Hospital

    Goshen, Indiana, 46526

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Cancer Centers of the Carolinas - Faris Road

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Central Indiana Cancer Centers - East

    Indianapolis, Indiana, 46219

  • Community Regional Cancer Care at Community Hospital East

    Indianapolis, Indiana, 46219

  • Community Regional Cancer Care at Community Hospital North

    Indianapolis, Indiana, 46256

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network at Southside Cancer Center

    Jacksonville, Florida, 32207

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Baptist Medical Center South

    Jacksonville, Florida, 32258

  • Integrated Community Oncology Network

    Jacksonville Beach, Florida, 32250

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Longview Cancer Center

    Longview, Texas, 75601

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Southwest General Health Center

    Middleburg Heights, Ohio, 44130

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Trinity CancerCare Center

    Minot, North Dakota, 58701

  • Memorial Medical Center

    Modesto, California, 95355

  • D.N. Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Cancer Center at Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • St. Luke's - Roosevelt Hospital Center - St.Luke's Division

    New York, New York, 10025

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • UMDNJ University Hospital

    Newark, New Jersey, 07103

  • Community Cancer Center

    Normal, Illinois, 61761

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • St. Joseph Hospital Regional Cancer Center - Orange

    Orange, California, 92868

  • UHHS Chagrin Highlands Medical Center

    Orange, Ohio, 44122

  • Integrated Community Oncology Network - Orange Park

    Orange Park, Florida, 32073

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, 32806

  • Florida Cancer Center - Palatka

    Palatka, Florida, 32177

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Feather River Hospital Cancer Center

    Paradise, California, 95969

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Sacred Heart Cancer Center at Sacred Heart Hospital

    Pensacola, Florida, 32504

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Frankford Hospital Cancer Center - Torresdale Campus

    Philadelphia, Pennsylvania, 19114

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina, 28374

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • All Saints Cancer Center at Wheaton Franciscan Healthcare

    Racine, Wisconsin, 53405

  • Cancer Centers of North Carolina - Raleigh

    Raleigh, North Carolina, 27607

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Renown Institute for Cancer at Renown Regional Medical Center

    Reno, Nevada, 89502

  • Saint Mary's Regional Medical Center

    Reno, Nevada, 89503

  • Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • University Radiation Oncology at Parkridge Hospital

    Rochester, New York, 14626

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Radiation Oncology Center - Roseville

    Roseville, California, 95661

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Flagler Cancer Center

    Saint Augustine, Florida, 32086

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Cancer Care Centers of South Texas - Northeast

    San Antonio, Texas, 78217

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Cancer Centers of the Carolinas - Seneca

    Seneca, South Carolina, 29672

  • Texas Oncology, PA at Texas Cancer Center - Sherman

    Sherman, Texas, 75090

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Baystate Regional Cancer Program at D'Amour Center for Cancer Care

    Springfield, Massachusetts, 01107

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Barnes-Jewish West County Hospital

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Saint Helena Hospital

    St. Helena, California, 94574

  • Stanford Cancer Center

    Stanford, California, 94305-5824

  • Door County Cancer Center at Door County Memorial Hospital

    Sturgeon Bay, Wisconsin, 54235-1495

  • Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land

    Sugar Land, Texas, 77479

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • J. Phillip Citta Regional Cancer Center at Community Medical Center

    Toms River, New Jersey, 08755

  • Arizona Oncology - Tucson

    Tucson, Arizona, 85704

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Washington Cancer Institute at Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • UHHS Westlake Medical Center

    Westlake, Ohio, 44145

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Riverview UW Cancer Center at Riverview Hospital

    Wisconsin Rapids, Wisconsin, 54494

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada6 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre at the University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • To compare the overall survival of patients with newly diagnosed, unresectable stage IIIA or IIIB non-small cell lung cancer treated with high- versus standard-dose conformal radiotherapy with concurrent and consolidation chemotherapy comprising carboplatin and paclitaxel.
  • To compare the overall survival of patients treated with versus without cetuximab in the setting of concurrent chemotherapy

Secondary

  • To compare progression-free survival and local-regional tumor control in patients treated with these regimens.
  • To compare the toxicity of high- versus standard-dose conformal radiotherapy and concurrent chemotherapy with versus without cetuximab in these patients.
  • To investigate the prognostic and predictive effects of gross tumor volume on overall survival of patients treated with these regimens.
  • To compare the quality of life of patients treated with these regimens.
  • To correlate outcomes (i.e., survival, toxicity, or QOL) in these patients with biological parameters.
  • To analyze the predictive value of pre-treatment standardized uptake value (SUV) of positron emission tomography (PET) scan in predicting survival, distant metastasis, and local-regional control in patients treated with these regimens.
  • To explore biological markers to predict clinical outcome including survival, distant metastasis, local-regional control, and QOL (including toxicity) in patients treated with these regimens.
  • To prospectively collect and bank tissue, blood, and urine specimens for future biomarker analyses in predicting clinical outcome in patients treated with these regimens.
  • To investigate associations between epidermal growth factor receptor (EGFR) expression and toxicity, response, overall survival, and progression-free survival.

OUTLINE: This is a multicenter study. Patients are stratified according to PET staging (yes vs no), radiotherapy technique (3-dimensional conformal radiotherapy vs intensity-modulated radiotherapy), Zubrod performance status (0 vs 1), and histology (squamous vs non-squamous). Patients are randomized to 1 of 4 treatment arms. (Arms II and IV closed to accrual effective 6/17/11)

Patients may undergo tumor tissue, blood, and urine collection periodically during study for tissue banking or biomarker correlative studies.

Patients may undergo quality-of-life assessment at baseline and periodically during study.

After completion of study therapy, patients are followed periodically for 5 years and then annually thereafter.

Being tested
Cetuximab, Carboplatin, Paclitaxel, 60 Gy RT, 74 Gy RT
Keywords
radiation toxicity, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Radiation Injuries, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetuximabBiological

    Also called Erbitux

    Loading dose: 400 mg/m2, IV, one week prior to start of radiation therapy (RT). Then, beginning day 1 of RT, 250 mg/m2, IV, weekly; for 60 Gy arm for 15 weeks, for 74 Gy arm for 16 weeks.

  • CarboplatinDrug

    Also called Paraplatin

    Concurrent: AUC=2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy; for 74 Gy arms, on day 43 as well.

    Consolidation, 3 weeks after completion of RT, AUC=6, IV, days 1 and 22.

  • PaclitaxelDrug

    Also called Taxol, Abraxane

    Concurrent: 45 mg/m2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy (RT); for 74 Gy arms, on day 43 as well.

    Consolidation, 3 weeks after completion of RT, 200 mg/m2, IV, days 1 and 22.

  • 60 Gy RTRadiation

    Also called RT

    Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 30 fractions over the course of 6 weeks.

  • 74 Gy RTRadiation

    Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 37 fractions over the course of 7.5 weeks.

Study groups in NCT00533949
Study groupRoleWhat they receive
60 Gy RTActive comparator60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
Receives: Drug: Carboplatin; Drug: Paclitaxel; Radiation: 60 Gy RT
74 Gy RTExperimental74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
Receives: Drug: Carboplatin; Drug: Paclitaxel; Radiation: 74 Gy RT
60 Gy RT + CetuximabExperimental60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
Receives: Biological: Cetuximab; Drug: Carboplatin; Drug: Paclitaxel; Radiation: 60 Gy RT
74 Gy RT + CetuximabExperimental74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
Receives: Biological: Cetuximab; Drug: Carboplatin; Drug: Paclitaxel; Radiation: 74 Gy RT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

    Measured: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

Secondary outcomes (12)

  1. Progression-free Survival

    A failure for progression-free survival (PFS) is the first occurrence of local or regional progression, distant metastases, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Time is measured from the date of randomization to the date of first failure. Patients without failure are censored at the date of last follow-up.

    Measured: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

  2. Local-regional Failure (Reported as Two-year Estimates)

    A failure for local-regional failure is the first occurrence of local or regional progression. Time is measured from the date of randomization to the date of first failure. Patients alive without local or regional failure at the time of last follow-up are censored. Patients who died without local or regional failure are considered as having competing risk at the time of death. Local-regional failure was estimated by the cumulative incidence method and 2 year estimates are reported.

    Measured: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

  3. Percentage of Participants With Grade 3-5 Esophagitis and Pneumonitis Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0

    Treatment-related esophagitis and pneumonitis were assessed graded using the CTCAE v3.0. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.

    Measured: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

  4. Percentage of Participants With Other Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0

    Treatment-related adverse events other than esophagitis and pneumonitis were assessed graded using the CTCAE v3.0. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.

    Measured: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

  5. Death During or Within 30 Days of Discontinuation of Protocol Treatment

    Deaths regardless of cause and occuring during or within 30 days of discontinuation of protocol treatment were evaluated.

    Measured: From start of protocol treatment to 24 months.

  6. Percentage of Patients With Decline From Baseline to 3 Months in the Lung Cancer Subscale (LCS) of the Functional Assessment of the Cancer Therapy Trial Outcome Index (FACT-TOI).

    A decline of 2 points in the LCS from baseline to 3 months was considered a clinically meaningful change indicating a decline in quality of life. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.

    Measured: At baseline and 3 months.

  7. Patient-reported Swallowing Score (Area Under the Curve)

    Patients completed a swallowing diary prior to the start of treatment and then daily during treatment. Patients recorded a score to indicate problems with swallowing on that day (1-None, 2-Mild soreness only, 3-Can swallow solids with some difficulty, 4-Cannot swallow solids, 5-Cannot swallow liquids). These scores were then plotted across time and the area under the curve from baseline until the end of week 6 was calculated. A lower area under the curve indicates better swallowing ability. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.

    Measured: From randomization to 6 weeks after start of radiation therapy (6-10 weeks from randomization)

  8. EuroQoL (EQ5D) Visual Analog Scale (VAS) Through One Year (Area Under the Curve)

    The visual analogue scale is a self-assessment of current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The area under the curve of each subject's EQ5D visual analog scale (VAS) response trajectory within 1 year was calculated. The EQ5D VAS utility was normalized by the baseline score. The trajectory included all available time points through one year. If a subject died within one year, the EQ5D VAS was reduced to 0 at the time of death. If subject was censored within one year, the EQ5D utility curve was truncated at the time of censoring. The scores were plotted across time and the area under the curve was calculated. A greater area under the curve indicates a better health state. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation

    Measured: From randomization to one year

  9. Overall Survival and Local-regional Failure by Epithelial Growth Factor Receptor (EGFR) Group

    EGFR is a protein that is present on the surface of both normal cells and cancer cancer cells. EGFR H-Score is a measure of staining intensity ranging from 0 to 300 where a higher value indicates greater intensity of EGFR. Available tumor samples were evaluated for EGFR and given an H-Score. Patients were divided into two groups based on H-Score values dichotomized at 200. All event times are time from randomization to date of event or censoring. A survival event is death from any cause, patients without events are censored at the date of last contact, and survival rates are estimated by Kaplan-Meier method. A local-regional event is the first development of progressive disease locally or regionally, patients who do not have an event are censored at the date of death or last contact, and event rates are estimated by cumulative incidence. Two-year rates are reported.

    Measured: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

  10. Percentage of Patients With Grade 3+ Adverse Events by Epithelial Growth Factor Receptor (EGFR) Group

    EGFR is a protein that is present on the surface of both normal cells and cancer cancer cells. EGFR H-Score is a measure of staining intensity ranging from 0 to 300 where a higher value indicates greater intensity of EGFR. Available tumor samples were evaluated for EGFR and given an H-Score. Patients were divided into two groups based on H-Score values dichotomized at 200. Worst toxicity as determined by adverse events was used as a measure of a patient's quality of life (QOL). Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Highest grade (worst) adverse event (AE) per subject was counted.

    Measured: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

  11. Prognostic and Predictive Effects of Gross Tumor Volume (GTV) on Overall Survival

    Gross tumor volume (GTV) is defined as the combined volume (cubic centimeters) of the primary tumor and clinically positive lymph nodes seen either on the planning computed tomography (CT) scan or the pretreatment positron emission tomography (PET) scan. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. GTV was evaluated as a continuous variable therefore overall survival time is not summarized by GTV. "Prognostic" refers to the main effect and "predictive" refers to the interaction between GTV and treatment arm.

    Measured: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

  12. Prognostic Value of Pre-treatment Standardized Uptake Value (SUV) of Positron Emission Tomography (PET) Scan in Predicting Survival, Distant Metastasis, and Local-regional Failure

    Standardized uptake value (SUV) is a simple way of determining activity in PET imaging. It is a mathematically derived ratio of tissue radioactivity concentration at a point in time and the injected dose of radioactivity per kilogram of the patient's body weight. All event times are time from randomization to date of event or censoring. A survival event is death from any cause, patients without events are censored at the date of last contact, and survival rates are estimated by Kaplan-Meier method. Local-regional and distant metastasis events are the first development of progressive disease locally/regionally or distant metastasis, respectively, patients who do not have an event are censored at the date of death or last contact, and event rates are estimated by cumulative incidence. Two-year rates are presented. PET SUV was evaluated as a continuous variable therefore the outcome variables are not summarized by PET SUV.

    Measured: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJun 2013
  4. Study completion20 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This study was revised 06/18/08 to a 2x2 factorial design to evaluate the addition of cetuximab to the radiation therapy regimens.
Masking
None (open label)
Enrolment
544 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00533949
Sponsor's protocol ID
RTOG 0617
Other IDs
CDR0000564240, NCCTG-N0628, CALGB-30609, NCI-2013-01762
Status last verified
May 2022
First submitted
20 Sep 2007
Last updated
21 Jun 2022
Data monitoring committee
Yes

Publications

  • Bradley JD, Hu C, Komaki RR, Masters GA, Blumenschein GR, Schild SE, Bogart JA, Forster KM, Magliocco AM, Kavadi VS, Narayan S, Iyengar P, Robinson CG, Wynn RB, Koprowski CD, Olson MR, Meng J, Paulus R, Curran WJ Jr, Choy H. Long-Term Results of NRG Oncology RTOG 0617: Standard- Versus High-Dose Chemoradiotherapy With or Without Cetuximab for Unresectable Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2020 Mar 1;38(7):706-714. doi: 10.1200/JCO.19.01162. Epub 2019 Dec 16.

    PubMed 31841363

  • Chun SG, Hu C, Komaki RU, Timmerman RD, Schild SE, Bogart JA, Dobelbower MC, Bosch W, Kavadi VS, Narayan S, Iyengar P, Robinson C, Rothman J, Raben A, Augspurger ME, MacRae RM, Paulus R, Bradley JD. Long-Term Prospective Outcomes of Intensity Modulated Radiotherapy for Locally Advanced Lung Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2024 Aug 1;10(8):1111-1115. doi: 10.1001/jamaoncol.2024.1841.

    PubMed 38935373

  • Zhang Z, Wang Z, Luo T, Yan M, Dekker A, De Ruysscher D, Traverso A, Wee L, Zhao L. Computed tomography and radiation dose images-based deep-learning model for predicting radiation pneumonitis in lung cancer patients after radiation therapy. Radiother Oncol. 2023 May;182:109581. doi: 10.1016/j.radonc.2023.109581. Epub 2023 Feb 25.

    PubMed 36842666

  • McWilliam A, Abravan A, Banfill K, Faivre-Finn C, van Herk M. Demystifying the Results of RTOG 0617: Identification of Dose Sensitive Cardiac Subregions Associated With Overall Survival. J Thorac Oncol. 2023 May;18(5):599-607. doi: 10.1016/j.jtho.2023.01.085. Epub 2023 Feb 3.

    PubMed 36738929

  • McKenzie E, Zhang S, Zakariaee R, Guthier CV, Hakimian B, Mirhadi A, Kamrava M, Padda SK, Lewis JH, Nikolova A, Mak RH, Atkins KM. Left Anterior Descending Coronary Artery Radiation Dose Association With All-Cause Mortality in NRG Oncology Trial RTOG 0617. Int J Radiat Oncol Biol Phys. 2023 Apr 1;115(5):1138-1143. doi: 10.1016/j.ijrobp.2022.11.033. Epub 2022 Nov 24.

    PubMed 36436615

  • Movsas B, Hu C, Sloan J, Bradley J, Komaki R, Masters G, Kavadi V, Narayan S, Michalski J, Johnson DW, Koprowski C, Curran WJ Jr, Garces YI, Gaur R, Wynn RB, Schallenkamp J, Gelblum DY, MacRae RM, Paulus R, Choy H. Quality of Life Analysis of a Radiation Dose-Escalation Study of Patients With Non-Small-Cell Lung Cancer: A Secondary Analysis of the Radiation Therapy Oncology Group 0617 Randomized Clinical Trial. JAMA Oncol. 2016 Mar;2(3):359-67. doi: 10.1001/jamaoncol.2015.3969.

    PubMed 26606200

  • Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16.

    PubMed 25601342

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cetuximab, Carboplatin and Paclitaxel in people with Lung Cancer and Radiation Toxicity, run by Radiation Therapy Oncology Group at 213 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 213 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00533949, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.

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