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Lung CancerPhase 3NCT00113386

Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer

A Phase 3 study testing filgrastim, pegfilgrastim and cisplatin in people with Lung Cancer, run by Radiation Therapy Oncology Group at 76 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
filgrastim, pegfilgrastim and cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
76 sitesUnited States
Study dates
Apr 2005to Feb 2009
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)*, including any of the following cellular types:
  • Adenocarcinoma
  • Squamous cell carcinoma
  • Large cell carcinoma
  • Non-lobar and non-diffuse bronchoalveolar cell carcinoma
  • NSCLC not otherwise specified NOTE: *Diagnosed within the past 3 months; diagnosis by mediastinal nodal biopsy or needle aspiration allowed provided a distinct lung primary (separate from the nodes) is clearly evident on CT scan
  • Stage IIIA disease
  • T1-T3 disease
  • If pleural effusion is present, must meet ≥ 1 of the following criteria to exclude T4 disease:
  • Pleural effusion cytologically negative by thoracentesis
  • Documented absence of pleural metastases and pleural effusion cytologically negative by thoracoscopy (for patients with pleural effusion on CT scan [but not on chest x-ray] that is deemed too small to tap safely under either CT scan or ultrasound guidance)
  • Confirmed positive ipsilateral mediastinal lymph node(s) (N2 disease)**, with or without positive ipsilateral hilar nodes, by mediastinoscopy, mediastinotomy, endoscopic ultrasound-guided transesophageal biopsy, thoracotomy, video-assisted thoracoscopy, Wang needles, or fine needle aspiration under bronchoscopic or CT guidance
  • N2 nodes must be separate from primary tumor by CT scan or surgical exploration AND maximum diameter ≤ 3.0 cm
  • Mediastinoscopy OR other means of mediastinal lymph node biopsy required (regardless of the primary tumor site) for patients with subcarinal lymphadenopathy by size criteria or by positron emission tomography (PET) scan
  • If the lymph nodes in the contralateral mediastinum and neck are visible by contrast CT scan of the chest AND are ≥ 1.0 cm OR if contralateral involvement is suggested by PET scan, lymph nodes must be confirmed negative by one of the above diagnostic procedures AND N3 status must be confirmed negative by histology or cytology
  • No palpable lymph nodes in the supraclavicular areas or higher in the neck unless proven benign by excisional biopsy
  • A nodal biopsy or needle aspiration may be omitted provided all of the following criteria are true:
  • Paralyzed left true vocal cord by bronchoscopy or indirect laryngoscopy
  • Nodes visible in the aortopulmonary window (level 5) region on CT scan
  • Distinct primary tumor (separate from the nodes) is visible by CT scan
  • No evidence of subcarinal nodal involvement by CT scan NOTE: **PET scan positivity is not sufficient to establish N2 nodal status
  • Measurable disease by chest x-ray and/or contrast-enhanced CT scan
  • Candidate for surgery
  • Resectable disease
  • No distant metastases, including other ipsilateral or contralateral parenchymal lesions or liver or adrenal metastases, by history or physical examination, fludeoxyglucose F 18 PET scan, MRI or CT scan of the brain, chest x-ray and/or CT scan of the lungs and upper abdomen

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,800/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)

Hepatic

  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • No hepatic insufficiency resulting in clinical jaundice or coagulation defects

Renal

  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No unstable angina or congestive heart failure requiring hospitalization within the past 6 months
  • No transmural myocardial infarction within the past 6 months

Pulmonary

  • FEV_1 ≥ 2.0 L OR
  • Predicted post-resection FEV_1 ≥ 0.8 L
  • DLCO ≥ 50% of predicted
  • No chronic obstructive pulmonary disease exacerbation
  • No other respiratory illness requiring hospitalization or that would preclude study therapy

Immunologic

  • No AIDS
  • No prior allergic reaction to the study drugs
  • No history of severe hypersensitivity to other drugs formulated with polysorbate 80
  • No acute bacterial or fungal infection requiring IV antibiotics

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No unintentional weight loss > 5% of body weight within the past 6 months
  • No pre-existing peripheral neuropathy ≥ grade 2
  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No other severe active comorbidity

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biological agent for this cancer
  • No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim during study induction therapy (for patients randomized to the chemoradiotherapy arm)

Chemotherapy

  • No prior systemic chemotherapy for this cancer
  • Prior chemotherapy for a different cancer allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
  • No routine post-operative radiotherapy
  • No concurrent intensity modulated radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No prior gefitinib for this cancer
  • No concurrent amifostine

Trial locations and contacts

76 sites in 1 country.

76 sites in 1 country

United States76 sites

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Cancer Center at Providence Alaska Medical Center

    Anchorage, Alaska, 99519-6604

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Memorial Hospital

    Colorado Springs, Colorado, 80909

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, 94524-4110

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80524

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Frederick Memorial Hospital Regional Cancer Therapy Center

    Frederick, Maryland, 21701

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Delnor Community Hospital - Geneva

    Geneva, Illinois, 60134

  • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27835-6028

  • CCOP - Greenville

    Greenville, South Carolina, 29615

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

    Hershey, Pennsylvania, 17033-0850

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • St. John's Regional Medical Center

    Joplin, Missouri, 64804

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28501

  • U.T. Cancer Institute at University of Tennessee Medical Center

    Knoxville, Tennessee, 37920-6999

  • Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Watson Clinic, LLC

    Lakeland, Florida, 33804-5000

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0293

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Dean Medical Center - Madison

    Madison, Wisconsin, 53717

  • Upper Michigan Cancer Center at Marquette General Hospital

    Marquette, Michigan, 49855

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Community Cancer Center

    Normal, Illinois, 61761

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina, 28374

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • Oregon Health & Science University Cancer Institute

    Portland, Oregon, 97239-3098

  • Reid Hospital & Health Care Services, Incorporated

    Richmond, Indiana, 47374

  • Valley Hospital - Ridgewood

    Ridgewood, New Jersey, 07450

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Vince Lombardi Cancer Clinic - Sheboygan

    Sheboygan, Wisconsin, 53081

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Madigan Army Medical Center - Tacoma

    Tacoma, Washington, 98431

  • Faxton Regional Cancer Center

    Utica, New York, 13502

  • York Cancer Center at Apple Hill Medical Center

    York, Pennsylvania, 17405

Other trials in United States

About this study

Official title: Phase III Randomized Trial of Preoperative Chemotherapy Versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients With Stage IIIA (N2) Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving cisplatin and docetaxel together with radiation therapy is more effective than giving cisplatin together with docetaxel in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying cisplatin, docetaxel, and radiation therapy to see how well they work compared to cisplatin and docetaxel in treating patients who are undergoing surgery for newly diagnosed stage III non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare overall survival of patients with newly diagnosed favorable prognosis stage IIIA non-small cell lung cancer treated with neoadjuvant cisplatin and docetaxel with vs without thoracic conformal radiotherapy followed by surgical resection and docetaxel.

Secondary

  • Compare median and progression-free survival of patients treated with these regimens.
  • Compare clinical and pathologic response rates in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Correlate pathological complete response with disease-free and overall survival of patients treated with these regimens.
  • Correlate DNA damage repair genes (ERCC1 and XRCC1), microtubule-related proteins (TUBB-III and MAP4), and shed tumor DNA with response and outcome in patients treated with these regimens.
  • Correlate protein profiles, using MALDI-TOF proteomic analysis of tumor and serum, with response and prognosis in patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Determine the efficacy of fludeoxyglucose F 18 positron emission tomography scanning in assessing pathological response of the tumor and the mediastinal lymph nodes and in predicting long-term outcome in patients treated with these regimens.
  • Correlate comorbid conditions with survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T stage (T1 vs T2-3), number of involved mediastinal lymph nodes (1 vs 2 or more vs not evaluable), and nodal micrometastases vs clinically involved nodes (mN2 vs cN2).

  • Induction therapy: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive cisplatin IV over 1 hour and docetaxel IV over 1 hour on days 1 and 22.
  • Arm II: Patients undergo thoracic conformal radiotherapy once daily 5 days a week for approximately 5½ weeks (total of 28 doses). Patients also receive cisplatin IV over 1 hour on days 1, 8, 22, and 29 and docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29.
  • Surgery: Within 4-8 weeks after completion of induction therapy, patients with stable disease or better undergo a lobectomy or pneumonectomy with a formal systematic mediastinal lymph node dissection.
  • Consolidation therapy: Beginning 4-6 weeks after surgery, patients receive docetaxel IV over 1 hour on days 1, 22, and 43 and pegfilgrastim or filgrastim (G-CSF) subcutaneously on days 2, 23, and 44.

Quality of life is assessed at baseline, within 2 weeks after completion of induction therapy, and then at 6 and 12 months after surgery.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 574 patients will be accrued for this study within 4 years.

Conditions
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, bronchoalveolar cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar

What participants receive

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

Study groups in NCT00113386
Study groupRoleWhat they receive
Induction chemotherapy, surgery, consolidation chemotherapyOtherInduction/surgery/consolidation
Receives: Biological: filgrastim; Biological: pegfilgrastim; Drug: cisplatin; Drug: docetaxel; Procedure: adjuvant therapy; Procedure: conventional surgery; Procedure: neoadjuvant therapy
Chemotherapy and radiation, surgery, consolidation chOtherInduction/radiation/surgery/cosolidation
Receives: Biological: filgrastim; Biological: pegfilgrastim; Drug: cisplatin; Drug: docetaxel; Procedure: adjuvant therapy; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy

What is being measured

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

  1. Comparison of Overall Survival

    Measured: Date of death or date of last follow-up

Timeline

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

  1. First posted8 Jun 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionFeb 2009

Why it stopped: This study terminated early due to low accrual.

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
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00113386
Sponsor's protocol ID
RTOG-0412
Other IDs
CDR0000429479, SWOG-S0332, CALGB-RTOG-0412, ECOG-RTOG-0412, NCCTG-RTOG-0412
Status last verified
Jun 2013
First submitted
7 Jun 2005
Last updated
28 Jun 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, pegfilgrastim and cisplatin in people with Lung Cancer, run by Radiation Therapy Oncology Group at 76 sites in United States.

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

Who may be eligible to take part?

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: stopped early, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States. 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 27 Dec 2012). 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?

Comparison of Overall Survival (time frame: Date of death or date of last follow-up). 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 NCT00113386.

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 28 Jun 2013.

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