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Combination Chemotherapy Plus Radiation Therapy With or Without Gefitinib in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
This study has been completed.
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: Southwest Oncology Group
Collaborators: National Cancer Institute (NCI)
North Central Cancer Treatment Group
NCIC Clinical Trials Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020709
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of tumors. It is not yet known whether combination chemotherapy plus radiation therapy is more effective with or without gefitinib in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with or without gefitinib in treating unresectable stage III non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: docetaxel
Drug: etoposide
Drug: gefitinib
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control
Official Title: A Phase III Trial Of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed By Maintenance Therapy With ZD 1839 Or Placebo In Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2001
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare cisplatin, etoposide, radiotherapy, and docetaxel with or without gefitinib, in terms of improving overall survival and progression-free survival, in patients with unresectable stage III non-small cell lung cancer.
  • Determine the toxicity profile of gefitinib in these patients.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to performance status (0 vs 1), stage (stage IIIA vs IIIB), measurability of lesion (measurable vs nonmeasurable), and histologic subtype (squamous vs nonsquamous).

Patients receive induction therapy comprising cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning within 24 hours after starting chemotherapy, patients receive concurrent induction radiotherapy 5 days a week for 5 weeks and then boost radiotherapy 5 days a week for 1.5 weeks.

Beginning approximately 4-8 weeks after completion of chemoradiotherapy, patients with stable or responding disease receive consolidation therapy comprising docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 3 courses.

Patients with stable or responding disease are randomized to one of two treatment arms for maintenance therapy. Patients begin maintenance therapy approximately 4-7 weeks after completion of consolidation therapy.

  • Arm I: Patients receive oral gefitinib daily.
  • Arm II: Patients receive oral placebo daily. In both arms, maintenance therapy continues for a maximum of 5 years in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 5 years and then annually for 5 years.

PROJECTED ACCRUAL: A total of 840 patients will be accrued for this study within 3.5 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed newly diagnosed single, primary bronchogenic non-small cell lung cancer (NSCLC)

    • Adenocarcinoma
    • Non-lobar and non-diffuse bronchoalveolar cell carcinoma
    • Large cell carcinoma
    • Squamous cell carcinoma
  • Unresectable stage IIIA disease

    • Histologically or cytologically confirmed N2 status
    • Multiple and/or bulky mediastinal lymph nodes on CT scan or x-ray
    • Ineligible for induction chemotherapy or chemoradiotherapy followed by surgical resection
    • Ineligible for or refused participation in SWOG-9336 OR
  • Stage IIIB disease

    • Pathologically or radiographically documented positive N3 nodes

      • No positive supraclavicular or scalene lymph nodes with disease extending up into the cervical region OR
    • Any documented T4 lesions invading the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina

      • Mediastinal involvement without organ involvement allowed if soft tissue mass extends directly into the mediastinum
      • Radiographic criteria for involvement of main pulmonary artery allowed if mediastinal soft tissue mass is present
  • Single primary parenchymal lesion

    • No other lesions on same or opposite sides of the lung
    • No metastatic disease involving the contralateral chest, liver, or adrenals by CT scan of upper abdomen
  • No malignant pleural or pericardial effusions

    • Pleural effusions visible only on CT scan or too small to tap allowed
  • Measurable or evaluable disease by CT scan, MRI, x-ray, or physical exam
  • No brain metastases

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Creatinine clearance at least 50 mL/min

Pulmonary:

  • FEV_1 at least 2.0 L OR
  • FEV_1 less than 2.0 L if predicted FEV_1 of the contralateral lung is greater than 800 mL by quantitative split function testing

Other:

  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other concurrent non-cancer-related illness that would preclude study therapy
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent colony-stimulating factors during induction therapy

Chemotherapy:

  • See Disease Characteristics
  • No prior chemotherapy for NSCLC

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy for NSCLC

Surgery:

  • No prior surgical resection of NSCLC
  • Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar diagnostic or staging surgery allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020709

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36607
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States, 85012
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Veterans Affairs Medical Center - Little Rock
Little Rock, Arkansas, United States, 72205
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
Veterans Affairs Medical Center - Loma Linda (Pettis)
Loma Linda, California, United States, 92357
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, District of Columbia
MBCCOP - Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153-5500
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615-7828
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, United States, 60612
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States, 60141
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7353
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0084
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40502-2236
United States, Louisiana
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71101-4295
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States, 48202
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0948
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
United States, North Dakota
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
Medcenter One Health System
Bismarck, North Dakota, United States, 58501-5505
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Dayton, Ohio, United States, 45429
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0501
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428-1002
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97201-3098
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States, 29401-5799
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital
Memphis, Tennessee, United States, 38104
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States, 38104
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Harrington Cancer Center
Amarillo, Texas, United States, 79106
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4095
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, United States, 79106
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78229
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112-5550
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Puget Sound Oncology Consortium
Seattle, Washington, United States, 98109
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
Canada
Centre Hospitalier Regional de Rimouski
Quebec, Canada, G1S 4L8
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Lethbridge Cancer Clinic
Lethbridge, Alberta, Canada, T1J 1W5
Canada, British Columbia
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2P9
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 6V5
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada, V8V 3N1
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
Nanaimo, British Columbia, Canada, V9S 2B7
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 3J5
Providence Health Care - Vancouver
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6ZB
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Cape Breton Cancer Centre
Sydney, Nova Scotia, Canada, B1P 1P3
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Algoma Regional Cancer Program at Sault Area Hospital
Sault Sainte Marie, Ontario, Canada, P6A 2C4
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Cancer Centre of Southeastern Ontario
Kingston, Ontario, Canada, K7L 5P9
Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Grand River Regional Cancer Centre at Grand River Hospital
Kitchner, Ontario, Canada, N2G 1G3
Hamilton and District Urology Research Group
Hamilton, Ontario, Canada, L8N 1T8
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada, L2R 5K3
Humber River Regional Hospital - Weston
Weston, Ontario, Canada, M9N 1N8
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Male Health Centre - North York
Toronto, Ontario, Canada, M6A 3B5
Male Health Centre - Oakville
Oakville, Ontario, Canada, L6H 3PI
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
North York General Hospital, Ontario
North York, Ontario, Canada, M2K 1E1
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Peterborough Oncology Clinic
Peterborough, Ontario, Canada, K9H 7B6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Royal Victoria Hospital of Barrie
Barrie, Ontario, Canada, L4M 6M2
Scarborough Hospital - General Site
Scarborough, Ontario, Canada, M1P 2V5
Markham Stouffville Hospital
Markham, Ontario, Canada, L6B IAI
St. Joseph's Health Centre - Toronto
Toronto, Ontario, Canada, M6R 1B5
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, Canada, M4N 3M5
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Trillium Health Centre - Mississauga
Mississauga, Ontario, Canada, L5B 1B8
William Osler Health Centre
Brampton, Ontario, Canada, L6W 2Z8
Canada, Prince Edward Island
Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, (P.Q.) H2X 3J4
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, Canada, J6E 6J2
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
CHUS-Hopital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, Canada, G7H 5H6
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Hopital du Saint-Sacrement, Quebec
Quebec City, Quebec, Canada, G1S 4L8
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Hotel Dieu de Montreal
Montreal, Quebec, Canada, H2W 1T8
Hotel-Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
L'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Southwest Oncology Group
North Central Cancer Treatment Group
NCIC Clinical Trials Group
Investigators
Study Chair: Karen Kelly, MD University of Colorado at Denver and Health Sciences Center
Study Chair: James R. Jett, MD Mayo Clinic
Study Chair: Yee C. Ung, MD, FRCPC Edmond Odette Cancer Centre at Sunnybrook
  More Information

Additional Information:
Publications:
Kelly K, Chansky K, Gaspar LE, Albain KS, Jett J, Ung YC, Lau DH, Crowley JJ, Gandara DR. Phase III Trial of Maintenance Gefitinib or Placebo After Concurrent Chemoradiotherapy and Docetaxel Consolidation in Inoperable Stage III Non-Small-Cell Lung Cancer: SWOG S0023. J Clin Oncol. 2008 Mar 31; [Epub ahead of print]
Kelly K, Chansky K, Gaspar LE, et al.: Updated analysis of SWOG 0023: a randomized phase III trial of gefitinib versus placebo maintenance after definitive chemoradiation followed by docetaxel in patients with locally advanced stage III non-small cell lung cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-7513, 388s, 2007.
Gaspar LE, McCoy J, Kelly K, et al.: Analysis of V20 and radiation pneumonitis on SWOG0023: a phase III trial of concurrent chemoradiation and docetaxel consolidation in stage III non-small cell lung cancer. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-108, S61-2, 2006.
Kelly K, Gaspar LE, Chansky K, et al.: Low incidence of pneumonitis on SWOG 0023: a preliminary analysis of an ongoing phase III trial of concurrent chemoradiotherapy followed by consolidation docetaxel and Iressa/placebo maintenance in patients with inoperable stage III non-small cell lung cancer. [Abstract] J Clin Oncol 23 (Suppl 16): A-7058, 634s, 2005.

Study ID Numbers: CDR0000068706, SWOG-S0023, CAN-NCIC-BR15, NCCTG-S0023
Study First Received: July 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00020709     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
squamous cell lung cancer
large cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Etoposide phosphate
Protein Kinase Inhibitors
Docetaxel
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Gefitinib
Etoposide
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009