Lung CancerPhase 3NCT00632853

Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

A Phase 3 study testing Standard Radiation Dose Therapy, cisplatin and etoposide in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 934 sites in 4 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer
What is being tested?: Standard Radiation Dose Therapy, cisplatin and etoposide
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 731 participants
Where: 934 sitesin 4 countries
Study dates: Mar 2008to 15 Apr 2026
Phase: Phase 3

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

Documentation of Disease
Histologically or cytologically documented small cell lung cancer (SCLC)
Limited-stage disease patients with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes

Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes are not eligible
Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not are not eligible unless they have a negative thoracentesis
Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray are not eligible

Measurable disease - Patients must have measurable disease, which includes lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques OR ≥ 1 cm by spiral CT scan
Prior Treatment
Patients may have received one and only one cycle of chemotherapy prior to enrolling on CALGB 30610, which must have included carboplatin or cisplatin and etoposide.
If a patient has had one cycle of cisplatin or carboplatin/etoposide prior to registration, the patient must have had all of it prior to registration tests as outlined in the protocol and prior to starting their first cycle of chemotherapy.
Additionally, these patients also must have met all of the eligibility criteria in the protocol prior to receiving the first cycle of chemotherapy.
Registration to CALGB 30610 must take place within 14-21 days after the start of the non-protocol therapy.
Failing to do all of the above will make the patient NOT eligible for CALGB 30610.
No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for SCLC
No prior mediastinal or thoracic radiotherapy
Patients with complete surgical resection of disease are not eligible
Age Requirement ≥ 18 years of age
ECOG Performance Status 0-2
Non-pregnant and non-nursing - No patients that are known to be pregnant or nursing
Required Initial Laboratory Values
Granulocytes ≥ 1,500/µl
Platelet count ≥ 100,000/µl
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST (SGOT) ≤ 2.0 times ULN
Serum creatinine ≤ 1.5 times ULN OR Calculated creatinine clearance ≥ 70 mL/min

Trial locations and contacts

934 sites in 4 countries.

Country

City, postcode or hospital

304 sites in 4 countries

United States300 sites

Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Summa Health System - Akron Campus
Akron, Ohio, 44304
Cleveland Clinic Akron General
Akron, Ohio, 44307
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
AdventHealth Altamonte
Altamonte Springs, Florida, 32701
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106
Community Hospital of Anaconda
Anaconda, Montana, 59711
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Alaska Regional Hospital
Anchorage, Alaska, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Katmai Oncology Group
Anchorage, Alaska, 99508
Providence Alaska Medical Center
Anchorage, Alaska, 99508
AnMed Health Cancer Center
Anderson, South Carolina, 29621
AnMed Health Hospital
Anderson, South Carolina, 29621
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915
PCR Oncology
Arroyo Grande, California, 93420
Cancer Care of Western North Carolina
Asheville, North Carolina, 28801
Mission Hospital
Asheville, North Carolina, 28801
Mountain Radiation Oncology PA
Asheville, North Carolina, 28801
AdventHealth Infusion Center Asheville
Asheville, North Carolina, 28803
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, 28816
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
MultiCare Auburn Medical Center
Auburn, Washington, 98001
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
The Medical Center of Aurora
Aurora, Colorado, 80012
University of Colorado Hospital
Aurora, Colorado, 80045
Rush - Copley Medical Center
Aurora, Illinois, 60504
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Veterans Administration Medical Center-Baltimore
Baltimore, Maryland, 21201
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Saint Agnes Hospital
Baltimore, Maryland, 21229
Summa Health System - Barberton Campus
Barberton, Ohio, 44203
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Ochsner Health Center-Summa
Baton Rouge, Louisiana, 70809
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana, 70809
Bronson Battle Creek
Battle Creek, Michigan, 49017
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Baptist Hospitals of Southeast Texas Cancer Center
Beaumont, Texas, 77701
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
Overlake Hospital Medical Center
Bellevue, Washington, 98004
Swedish Cancer Institute-Eastside Oncology Hematology
Bellevue, Washington, 98005
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Saint Charles Health System
Bend, Oregon, 97701
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722
Billings Clinic Cancer Center
Billings, Montana, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101
Saint Vincent Healthcare
Billings, Montana, 59101
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
The Kirklin Clinic at Acton Road
Birmingham, Alabama, 35243
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Saint Joseph Medical Center
Bloomington, Illinois, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Boulder Community Hospital
Boulder, Colorado, 80301
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
21st Century Oncology - Bradenton
Bradenton, Florida, 34210
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310
Harrison Medical Center
Bremerton, Washington, 98310
Transylvania Regional Hospital
Brevard, North Carolina, 28712
United Hospital Center
Bridgeport, West Virginia, 26330
Steward Saint Elizabeth's Medical Center
Brighton, Massachusetts, 02135
IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan, 48114
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114
Wellmont Bristol Regional Medical Center
Bristol, Tennessee, 37620
Wellmont Medical Associates Oncology and Hematology-Bristol
Bristol, Tennessee, 37620
Wellmont Medical Associates-Bristol
Bristol, Virginia, 24201
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045
Crozer-Keystone Regional Cancer Center at Broomall
Broomall, Pennsylvania, 19008
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Veterans Affairs Western New York Health Care System-Buffalo
Buffalo, New York, 14215
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Highline Medical Center-Main Campus
Burien, Washington, 98166
Mills-Peninsula Medical Center
Burlingame, California, 94010
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
Sands Cancer Center
Canandiaqua, New York, 14424
Graham Hospital Association
Canton, Illinois, 61520
Illinois CancerCare-Canton
Canton, Illinois, 61520
IHA Hematology Oncology Consultants-Canton
Canton, Michigan, 48188
Saint Joseph Mercy Canton
Canton, Michigan, 48188
Aultman Health Foundation
Canton, Ohio, 44710
Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Caro Cancer Center
Caro, Michigan, 48723
Tanner Medical Center/Carrollton
Carrollton, Georgia, 30117
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
SIH Cancer Institute
Carterville, Illinois, 62918
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Memorial Hospital
Carthage, Illinois, 62321
Rocky Mountain Oncology
Casper, Wyoming, 82609
East Bay Radiation Oncology Center
Castro Valley, California, 94546
Eden Hospital Medical Center
Castro Valley, California, 94546
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720
Centralia Oncology Clinic
Centralia, Illinois, 62801
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Geauga Hospital
Chardon, Ohio, 44024
Medical University of South Carolina
Charleston, South Carolina, 29425
West Virginia University Charleston Division
Charleston, West Virginia, 25304
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28207
Southern Oncology Specialists-Charlotte
Charlotte, North Carolina, 28262
Memorial Hospital
Chattanooga, Tennessee, 37404
IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan, 48118
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118
Saint Luke's Hospital
Chesterfield, Missouri, 63017
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Rush University Medical Center
Chicago, Illinois, 60612
Swedish Covenant Hospital
Chicago, Illinois, 60625
Presence Resurrection Medical Center
Chicago, Illinois, 60631
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Adena Regional Medical Center
Chillicothe, Ohio, 45601
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Bethesda North Hospital
Cincinnati, Ohio, 45242
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
21st Century Oncology MHP - Clarkston
Clarkston, Michigan, 48346
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
Case Western Reserve University
Cleveland, Ohio, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Community Cancer Institute
Clovis, California, 93611
University Oncology Associates
Clovis, California, 93611
Big Horn Basin Cancer Center
Cody, Wyoming, 82414
Billings Clinic-Cody
Cody, Wyoming, 82414
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212
John B Amos Cancer Center
Columbus, Georgia, 31904
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Riverside Methodist Hospital
Columbus, Ohio, 43214
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215
Grant Medical Center
Columbus, Ohio, 43215
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Mount Carmel Health Center West
Columbus, Ohio, 43222
Doctors Hospital
Columbus, Ohio, 43228
Memorial Sloan Kettering Commack
Commack, New York, 11725
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
MD Anderson in The Woodlands
Conroe, Texas, 77384
Cookeville Regional Medical Center
Cookeville, Tennessee, 38501
Mercy Hospital
Coon Rapids, Minnesota, 55433
Bay Area Hospital
Coos Bay, Oregon, 97420
Northshore Oncology Associates-Covington
Covington, Louisiana, 70433
Greater Regional Medical Center
Creston, Iowa, 50801
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Parkland Memorial Hospital
Dallas, Texas, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Carle on Vermilion
Danville, Illinois, 61832
Mercy Fitzgerald Hospital
Darby, Pennsylvania, 19023-1291
Dayton Veterans Affairs Medical Center
Dayton, Ohio, 45428
Beaumont Hospital - Dearborn
Dearborn, Michigan, 48124
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Heartland Cancer Research NCORP
Decatur, Illinois, 62526
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Delaware Radiation Oncology
Delaware, Ohio, 43015
Grady Memorial Hospital
Delaware, Ohio, 43015
National Jewish Health-Main Campus
Denver, Colorado, 80206
Porter Adventist Hospital
Denver, Colorado, 80210
University of Colorado
Denver, Colorado, 80217-3364
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Rose Medical Center
Denver, Colorado, 80220
Mercy Capitol
Des Moines, Iowa, 50307
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Ascension Saint John Hospital
Detroit, Michigan, 48236
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
Kaiser Permanente Dublin
Dublin, California, 94568
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512
Mercy Medical Center
Durango, Colorado, 81301
Southwest Oncology PC
Durango, Colorado, 81301
Duke University Medical Center
Durham, North Carolina, 27710
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Great Lakes Cancer Management Specialists-Doctors Park
East China, Michigan, 48054
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Fairview-Southdale Hospital
Edina, Minnesota, 55435
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
21st Century Oncology - El Segundo
El Segundo, California, 90245
Elkhart Clinic
Elkhart, Indiana, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514
Elkhart General Hospital
Elkhart, Indiana, 46515
Union Hospital of Cecil County
Elkton, Maryland, 21921
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
Epic Care Partners in Cancer Care
Emeryville, California, 94608
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
Swedish Medical Center
Englewood, Colorado, 80113
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522
Ephrata Community Hospital
Ephrata, Pennsylvania, 17522
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49829
Eureka Hospital
Eureka, Illinois, 61530
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Saint Francis Hospital
Evanston, Illinois, 60202
Deaconess Clinic Downtown
Evansville, Indiana, 47713
Providence Regional Cancer Partnership
Everett, Washington, 98201
Exeter Hospital
Exeter, New Hampshire, 03833
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Clinic North-Fargo
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
21st Century Oncology MHP - Farmington
Farmington Hills, Michigan, 48334
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Beaumont Hospital - Farmington Hills
Farmington Hills, Michigan, 48336
Simonds-Sinon Regional Cancer Center
Fitchburg, Massachusetts, 01420
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Hurley Medical Center
Flint, Michigan, 48503
Saint Agnes Hospital/Agnesian Cancer Center
Fond du Lac, Wisconsin, 54935
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
21st Century Oncology - Fort Walton Beach
Fort Walton Beach, Florida, 32547
Radiation Oncology Associates PC
Fort Wayne, Indiana, 46804
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
Angel Medical Center
Franklin, North Carolina, 28734
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132
Kaiser Permanente-Fremont
Fremont, California, 94538
Fresno Cancer Center
Fresno, California, 93720
Kaiser Permanente-Fresno
Fresno, California, 93720
Unity Hospital
Fridley, Minnesota, 55432
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, 83619
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401

Other trials in United States

Puerto Rico2 sites

San Juan Community Oncology Group
San Juan, 00917
San Juan City Hospital
San Juan, 00936

Other trials in Puerto Rico

Israel1 site

Rabin Medical Center
Petah Tikva, 49100

Other trials in Israel

South Korea1 site

Yonsei University Health System-Severance Hospital
Seoul, 120-752

Other trials in South Korea

About this study

Official title: Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

Read the detailed description

OUTLINE: This is a 2-part, multicenter, randomized study. Patients are stratified according to gender, weight loss 6 months prior to study entry (≤ 5% of body weight vs > 5% of body weight), ECOG performance status (0 vs 1 vs 2), radiotherapy technique (intensity-modulated radiotherapy vs 3-dimensional conformal radiotherapy), radiotherapy start time (at first cycle of protocol chemotherapy, after one cycle of prior non-protocol chemotherapy vs at first cycle of protocol chemotherapy, without prior non-protocol chemotherapy vs at second cycle of protocol chemotherapy, without prior non-protocol chemotherapy) and chemotherapy backbone: carboplatin vs cisplatin.

OBJECTIVES:

Primary Objective

To determine whether administering high dose thoracic radiotherapy, 70 Gy (2 Gy once-daily over 7 weeks) or 61.2 Gy (1.8 Gy once-daily for 16 days followed by 1.8 Gy twice-daily for 9 days), will improve median and 2-year survival compared with 45 Gy (1.5 Gy twice-daily over 3 weeks) in patients with limited stage small cell lung cancer.

Secondary Objectives

To compare treatment related toxic effects of thoracic radiotherapy regimens in patients with limited stage small cell lung cancer
To compare response rates, failure-free survival and toxicity of thoracic radiotherapy regimens in patients with limited stage small cell lung cancer
To compare rates of local relapse, distant metastases and brain metastases with these regimens
To compare patients' quality of life between these treatment regimens in terms of their physical symptoms, physical functioning and psychological state
To describe the patterns of use of thoracic intensity modulated radiation therapy (IMRT) in patients with limited stage small cell lung cancer
To examine blood-based biomarkers of response and resistance to cisplatin (or carboplatin) and etoposide
To evaluate the correspondence between increases in plasma ProGRP concentrations and disease progression/recurrence
To evaluate the potential for plasma ProGRP concentrations at baseline, after each cycle of chemotherapy and at first evaluation following completion of chemotherapy to predict PFS and OS
To evaluate the correspondence between longitudinal decreases in plasma ProGRP concentrations and clinical response

Part 1: Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients undergo standard-dose (45 Gy given in 30 treatments) thoracic radiotherapy twice daily, 5 days a week, for 3 weeks. Patients also receive cisplatin IV on day 1 or carboplatin IV and etoposide IV on days 1, 2, and 3.

Arm II: Patients undergo higher-dose (70 Gy given in 35 treatments) thoracic radiotherapy once daily, 5 days a week, for 7 weeks. Patients also receive cisplatin or carboplatin and etoposide as in arm I.

Arm III: (discontinued as of 03/10/13) Patients undergo mid-dose (61.2 Gy given in 34 treatments) thoracic radiotherapy once daily, 5 days a week, during the initial 16 days (approximately 3 weeks) of treatment and then twice daily, 5 days a week, for the final 9 days (approximately 2 weeks) of treatment. Patients also receive cisplatin and etoposide.

In all arms, treatment with cisplatin and etoposide repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Part 2: An interim analysis was conducted after accrual of 30 patients per arm and one experimental arm based upon a comparison of treatment-related toxicity was selected. The most toxic experimental arm was discontinued, and the trial continues comparing standard therapy (arm I) to the selected experimental regimen (arm II) as described in part 1. Please see the Arms section for more information regarding Part 2.

Prophylactic cranial irradiotherapy (PCI): Within 3-6 weeks after completion of chemotherapy, PCI should be offered to all patients with a complete tumor response (CR) or near complete response (nCR) with only residual chest abnormalities of indeterminate nature following completion of combined modality therapy.

After completion of study treatment, patients are followed up at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years or until disease progression. At disease progression, patients are followed up every 6 months.

Conditions: Lung Cancer
Being tested: Standard Radiation Dose Therapy, cisplatin, etoposide, High Radiation Dose Therapy, carboplatin
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.

Standard Radiation Dose TherapyRadiation
45 Gy
cisplatinDrug
IV
etoposideDrug
IV
High Radiation Dose TherapyRadiation
70 Gy
carboplatinDrug
IV

Study groups in NCT00632853
Study group	Role	What they receive
Arm A - Standard Radiotherapy + Chemotherapy	Active comparator	Radiotherapy (every day, Monday-Friday, for a total of 3 weeks) XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks): * Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days * Etoposide 100 mg/m2 IV Register/ on days 1, 2, and 3, every 21 days Receives: Radiation: Standard Radiation Dose Therapy; Drug: cisplatin; Drug: etoposide; Drug: carboplatin
Arm B - High Dose Radiotherapy + Chemotherapy	Experimental	Radiotherapy (every day, Monday-Friday, for a total of 7 weeks) XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks): * Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days * Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days Receives: Drug: cisplatin; Drug: etoposide; Radiation: High Radiation Dose Therapy; Drug: carboplatin

What is being measured

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

Overall Survival Time
Overall survival time is defined as the time between a patient's registration and death or end of survival follow up.
Measured: 11.25 years

Secondary outcomes (9)

Complete and Partial Response Rates
Measured: 11.25 years
Failure-free>> Survival
Measured: Up to 5 years
To Compare Rates of Local Relapse, Distant Metastases and Brain Metastases With These > Regimens.
Measured: 5 years
To Compare Patients' Quality of Life Between These Treatment Regimens in Terms of Their > Physical Symptoms, Physical Functioning and Psychological State.
Measured: 5 years
To Describe the Patterns of Use of Thoracic Intensity Modulated Radiation Therapy (IMRT) in Patients With Limited Stage Small Cell Lung Cancer.
Measured: 5 years
To Examine Blood-based Biomarkers of Response and Resistance to Cisplatin (or Carboplatin) and Etoposide.
Measured: 5 years
To Evaluate the Correspondence Between Increases in Plasma ProGRP Concentrations and Disease Progression/Recurrence
Measured: 5 years
To Evaluate the Potential for Plasma ProGRP Concentrations at Baseline, After Each Cycle of > Chemotherapy and at First Evaluation Following Completion of Chemotherapy to Predict PFS and OS.
Measured: 5 years
To Evaluate the Correspondence Between Longitudinal Decreases in Plasma ProGRP Concentrations and Clinical Response.
Measured: 5 years

Timeline

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

Mar 200815 Apr 2026

First posted11 Mar 2008 (estimated)
Study startMar 2008
Primary completion2 Mar 2022
Study completion15 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 731 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00632853
Sponsor's protocol ID: CALGB-30610
Other IDs: CALGB-30610, RTOG 0538, U10CA031946, CDR0000588879, NCI-2009-00470
Status last verified: May 2026
First submitted: 8 Mar 2008
Last updated: 10 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Publications

Farris MK, Mix MD, Wang X, Jaszewski B, Foster N, Masters GA, Laurie F, Smith K, Razavian NB, Alden RS, Komaki R, Stinchcombe TE, Bradley JD, Vokes EE, Bogart J. Prognostic Factors in Limited-Stage Small Cell Lung Cancer: A Secondary Analysis of CALGB 30610-RTOG 0538. JAMA Netw Open. 2024 Oct 1;7(10):e2440673. doi: 10.1001/jamanetworkopen.2024.40673.
PubMed 39446327
Bogart J, Wang X, Masters G, Gao J, Komaki R, Gaspar LE, Heymach J, Bonner J, Kuzma C, Waqar S, Petty W, Stinchcombe TE, Bradley JD, Vokes E. High-Dose Once-Daily Thoracic Radiotherapy in Limited-Stage Small-Cell Lung Cancer: CALGB 30610 (Alliance)/RTOG 0538. J Clin Oncol. 2023 May 1;41(13):2394-2402. doi: 10.1200/JCO.22.01359. Epub 2023 Jan 9.
PubMed 36623230