AzTrials
AzTrials

Lung CancerPhase 2NCT00057746

Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer

A Phase 2 study testing Prophylactic cranial irradiation, 2.5 Gy fx, Prophylactic cranial irradiation, 2.0 Gy fx and Prophylactic cranial irradiation, 1.5 Gy fx in people with Lung Cancer, run by Radiation Therapy Oncology Group at 222 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 damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy. Read more about this study

Who is it for?
Ages Up to 120 years
Conditions the study is for
Lung Cancer
What is being tested?
Prophylactic cranial irradiation, 2.5 Gy fx, Prophylactic cranial irradiation, 2.0 Gy fx and Prophylactic cranial irradiation, 1.5 Gy fx
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
222 sitesin 2 countries
Study dates
Feb 2003to Nov 2013
Phase
Phase 2
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 Up to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa
  • Limited stage (I-IIIB)
  • Confined to 1 hemithorax
  • No T4 based on malignant pleural effusion, or N3 disease based on contralateral hilar or contralateral supraclavicular involvement
  • Complete response after induction chemotherapy (with or without thoracic radiotherapy)
  • Consolidative chest radiotherapy may be initiated before study
  • No radiographic evidence of any of the following:
  • Brain metastases
  • Normal brain CT scan or MRI less than 1 month before study
  • Ipsilateral lung metastases
  • Malignant pleural effusion
  • Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 10.0 g/dL^

Hepatic

  • Not specified

Renal

  • Not specified

Pulmonary

  • See Disease Characteristics

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Neurological function class 1 or 2
  • No epilepsy requiring permanent oral medication
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other serious medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • At least 1 week since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
  • Concurrent thoracic radiotherapy allowed

Surgery

  • Not specified

Other

  • No concurrent antitumor agents

Trial locations and contacts

222 sites in 2 countries.

222 sites in 2 countries

United States217 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Saint John's Cancer Center at Saint John's Medical Center

    Anderson, Indiana, 46016

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Arlington Cancer Center - Arlington

    Arlington, Texas, 76012-2510

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Auburn Radiation Oncology

    Auburn, California, 95603

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • St. Luke's Cancer Network at St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, 35294

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Ocean Medical Center at Meridian Health

    Brick, New Jersey, 08724

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Radiation Oncology Centers - Cameron Park

    Cameron Park, California, 95682

  • Graham Hospital

    Canton, Illinois, 61520

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Cancer Institute of Cape Girardeau, LLC

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Huron Hospital Cancer Care Center

    Cleveland, Ohio, 44112

  • Euclid Hospital

    Cleveland, Ohio, 44119

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Memorial Hospital Cancer Center - Colorado Springs

    Colorado Springs, Colorado, 80909

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

    Dallas, Texas, 75390

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Dale and Frances Hughes Cancer Center at Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • St. Anthony's Memorial Hospital

    Effingham, Illinois, 62401

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Union Hospital Cancer Program at Union Hospital

    Elkton MD, Maryland, 21921

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Hudner Oncology Center at Saint Anne's Hospital - Fall River

    Fall River, Massachusetts, 02721

  • Parkview Regional Cancer Center at Parkview Health

    Fort Wayne, Indiana, 46805

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Metro Health Hospital

    Grand Rapids, Michigan, 49506

  • Three Rivers Community Hospital

    Grants Pass, Oregon, 97527

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

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

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27835-6028

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Mason District Hospital

    Havana, Illinois, 62644

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

    Hershey, Pennsylvania, 17033-0850

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

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

    Houston, Texas, 77030-4009

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Veterans Affairs Medical Center - Indianapolis

    Indianapolis, Indiana, 46202

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Immanuel St. Joseph's

    Mankato, Minnesota, 56002

  • MedCentral - Mansfield Hospital

    Mansfield, Ohio, 44903

  • 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

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Dubs Cancer Center at Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Providence Cancer Center at PMCC

    Medford, Oregon, 97504

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Tucker Center for Cancer Care at Orange Regional Medical Center

    Middletown, New York, 10940-4199

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Cancer Center at Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Hackley Hospital

    Muskegon, Michigan, 49442

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Regional Cancer Center at Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Bay Medical

    Panama City, Florida, 32401

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Fox Chase Cancer Center CCOP Research Base

    Philadelphia, Pennsylvania, 19140

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • Arizona Oncology Services Foundation

    Phoenix, Arizona, 85013

  • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • Legacy Good Samaritan Hospital & Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center and Children's Hospital

    Portland, Oregon, 97227

  • Hudson Valley Oncology Associates

    Poughkeepsie, New York, 12601

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • South Suburban Oncology Center

    Quincy, Massachusetts, 02169

  • All Saints Cancer Center at Wheaton Franciscan Healthcare

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

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

    Reading, Pennsylvania, 19612-6052

  • Booker Cancer Center at Riverview Medical Center

    Red Bank, New Jersey, 07701

  • Radiation Oncology Associates - Reno

    Reno, Nevada, 89509

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • 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

  • Mercy General Hospital

    Sacramento, California, 95819

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

    Salem, Ohio, 44460

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn

    Scottsdale, Arizona, 85251

  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

    Scottsdale, Arizona, 85260

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98112

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

    Seattle, Washington, 98122-4307

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Frederick R. and Betty M. Smith Cancer Treatment Center

    Sparta, New Jersey, 07871

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Valley Cancer Center

    Spring Valley, Illinois, 61362

  • Highlands Oncology Group - Springdale

    Springdale, Arkansas, 72764

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Madigan Army Medical Center - Tacoma

    Tacoma, Washington, 98431

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

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

    Toms River, New Jersey, 08755

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66606

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Solano Radiation Oncology Center

    Vacaville, California, 95687

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

    Vineland, New Jersey, 08360

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • South Pointe Hospital Cancer Care Center

    Warrensville Heights, Ohio, 44122

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Schiffler Cancer Center at Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • York Cancer Center at Apple Hill Medical Center

    York, Pennsylvania, 17405

Other trials in United States

Canada5 sites

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • McGill Cancer Centre at McGill University

    Montreal, H2W 1S6

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Phase II Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy.

PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).

Read the detailed description

OBJECTIVES:

  • Compare the incidence of chronic neurotoxicity in patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days vs 181-240 days). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week. Treatment continues for 2 weeks in the absence of unacceptable toxicity.
  • Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6 weeks in the absence of unacceptable toxicity.
  • Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4 weeks in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3 years.

Patients are followed every 6 months for 1 year and then annually for 3 years.

PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study within 3.5 years.

Conditions
Lung Cancer
Being tested
Prophylactic cranial irradiation, 2.5 Gy fx, Prophylactic cranial irradiation, 2.0 Gy fx, Prophylactic cranial irradiation, 1.5 Gy fx
Keywords
limited stage small cell lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Prophylactic cranial irradiation, 2.5 Gy fxRadiation

    Also called PCI

    Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy

  • Prophylactic cranial irradiation, 2.0 Gy fxRadiation

    Also called PCI

    Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy

  • Prophylactic cranial irradiation, 1.5 Gy fxRadiation

    Also called PCI

    Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy

Study groups in NCT00057746
Study groupRoleWhat they receive
Arm IActive comparatorProphylactic cranial irradiation, 2.5 Gy fx
Receives: Radiation: Prophylactic cranial irradiation, 2.5 Gy fx
Arm IIExperimentalProphylactic cranial irradiation, 2.0 Gy fx
Receives: Radiation: Prophylactic cranial irradiation, 2.0 Gy fx
Arm IIIExperimentalProphylactic cranial irradiation, 1.5 Gy fx
Receives: Radiation: Prophylactic cranial irradiation, 1.5 Gy fx

What is being measured

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

  1. Incidence of Chronic Neurotoxicity

    Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.

    Measured: From study registration to one year.

Timeline

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

  1. First posted9 Apr 2003 (estimated)
  2. Study startFeb 2003
  3. Primary completionMay 2009
  4. Study completionNov 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00057746
Sponsor's protocol ID
RTOG-0212
Other IDs
CDR0000258668
Status last verified
Apr 2016
First submitted
7 Apr 2003
Last updated
25 May 2016
Data monitoring committee
Yes

Publications

  • Gondi V, Paulus R, Bruner D, et al.: Prognostic significance of QOL deterioration during early lung cancer survivorship: secondary analysis of RTOG 0212 and 0214. [Abstract] J Clin Oncol 29 (Suppl 15): A-6061, 2011.

  • Le Pechoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 May;10(5):467-74. doi: 10.1016/S1470-2045(09)70101-9. Epub 2009 Apr 20.

    PubMed 19386548

  • Pechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008.

  • Wolfson AH, Bae K, Komaki R, Meyers C, Movsas B, Le Pechoux C, Werner-Wasik M, Videtic GM, Garces YI, Choy H. Primary analysis of a phase II randomized trial Radiation Therapy Oncology Group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limited-disease small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):77-84. doi: 10.1016/j.ijrobp.2010.05.013. Epub 2010 Aug 26.

    PubMed 20800380

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prophylactic cranial irradiation, 2.5 Gy fx, Prophylactic cranial irradiation, 2.0 Gy fx and Prophylactic cranial irradiation, 1.5 Gy fx in people with Lung Cancer, run by Radiation Therapy Oncology Group at 222 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?

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 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 222 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 25 May 2016). 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?

Incidence of Chronic Neurotoxicity (time frame: From study registration to one year.). 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 NCT00057746, which also lists 4 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 25 May 2016.

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