Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer

A Phase I/II Escalation Study of Thoracic Irradiation With Concurrent Chemotherapy for Patients With Limited Small Cell Lung Cancer

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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients with limited-stage small cell lung cancer.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: radiation therapy; Drug: etoposide; Drug: cisplatin

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of thoracic radiation using an accelerated boost with concurrent chemotherapy in patients with small cell lung cancer. II. Evaluate the response rate and overall survival in these patients. III. Reduce the toxic effects of treatment to esophagus and lungs.

OUTLINE: This is a radiation dose escalation study. Patients are sequentially accrued to one of four radiation dose levels. Dose level 1: Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given daily for 2 days, then twice daily for 3 days during week 5. (Closed to accrual 6/98) Dose level 2: Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given twice daily for 5 days during week 5. (Closed to accrual 9/24/99) Dose level 3: Patients receive radiotherapy 5 days a week for 18 days followed by radiation boost given in the evenings on days 19 and 20, then twice daily for 5 days during week 5. (Closed to accrual 5/5/00) Dose level 4: Patients receive radiotherapy 5 days a week for 16 days followed by radiation boost given in the evenings on days 17-20, then twice daily for 5 days during week 5. The fifth dose level is the same as the first dose level. (Closed to accrual 3/19/99) Cohorts of 5 patients are entered at each radiation dose level. If one patient experiences nonhematologic dose limiting toxicity (DLT), 5 additional patients are treated at that level. If no further DLT occurs, escalation to the next arm proceeds. Patients receive cisplatin IV plus etoposide IV on day 1 of radiotherapy and oral etoposide on days 2 and 3 every 3 weeks for 4 courses. Patients are followed every 3 months for 1 year, every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10 months.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center - Calgary
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital
  • Newfoundland and Labrador
    • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
      • Newfoundland Cancer Treatment and Research Foundation
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Cancer Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Cancer Care Ontario-Hamilton Regional Cancer Centre
    • Kingston, Ontario, Canada, K7L 5P9
      • Kingston Regional Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • Cancer Care Ontario-London Regional Cancer Centre
    • Ottawa, Ontario, Canada, K1H 1C4
      • Ottawa Regional Cancer Centre - General Campus
    • Sudbury, Ontario, Canada, P3E 5J1
      • Northeastern Ontario Regional Cancer Centre, Sudbury
    • Thunder Bay, Ontario, Canada, P7A 7T1
      • Northwestern Ontario Regional Cancer Centre, Thunder Bay
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto Sunnybrook Regional Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
  • Quebec
    • Fleurimont, Quebec, Canada, J1H 5N4
      • CHUS-Hopital Fleurimont
    • Montreal, Quebec, Canada, H2W 1S6
      • McGill University
    • Montreal, Quebec, Canada, H2L-4M1
      • Centre Hospitalier de l'Universite de Montreal
    • Quebec City, Quebec, Canada, G1R 2J6
      • CHU de Quebec - L'Hotel-Dieu de Quebec
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3300
      • University of Alabama at Birmingham Comprehensive Cancer Center
    • Huntsville, Alabama, United States, 35801
      • Comprehensive Cancer Institute of Huntsville
    • Huntsville, Alabama, United States, 35801-4470
      • Huntsville Hospital System
    • Mobile, Alabama, United States, 36688
      • MBCCOP - Gulf Coast
    • Montgomery, Alabama, United States, 36106-2801
      • Alabama Oncology, LLC
    • Tuscallosa, Alabama, United States, 35401
      • Radiation Oncology Associates of West Alabama
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Providence Alaska Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Foundation for Cancer Research and Education
    • Tucson, Arizona, United States, 85724
      • Arizona Cancer Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Concord, California, United States, 94524-4110
      • Mount Diablo Medical Center
    • Duarte, California, United States, 91010-3000
      • Cancer Center and Beckman Research Institute, City of Hope
    • Fresno, California, United States, 93720
      • California Cancer Center
    • Fresno, California, United States, 93720
      • Saint Agnes Cancer Center
    • Glendale, California, United States, 91204
      • Glendale Memorial Hospital and Health Center
    • Greenbrae, California, United States, 94904
      • Sutter Health West Cancer Research Group
    • La Jolla, California, United States, 92093-0658
      • University of California San Diego Cancer Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Long Beach, California, United States, 90822
      • Veterans Affairs Medical Center - Long Beach
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center, UCLA
    • Los Angeles, California, United States, 90033-0804
      • USC/Norris Comprehensive Cancer Center and Hospital
    • Oakland, California, United States, 94609-3305
      • CCOP - Bay Area Tumor Institute
    • Pasadena, California, United States, 91105
      • Huntington Cancer Center
    • Pomona, California, United States, 91767
      • Cancer Care Center
    • Sacramento, California, United States, 95816
      • Radiation Oncology Center - Sacramento
    • San Diego, California, United States, 92101-1492
      • Radiation Medical Group, Inc.
    • San Francisco, California, United States, 94143-0128
      • UCSF Cancer Center and Cancer Research Institute
    • San Jose, California, United States, 95128
      • O'Connor Hospital
    • Santa Rosa, California, United States, 95403
      • CCOP - Santa Rosa Memorial Hospital
    • Travis Air Force Base, California, United States, 94535
      • David Grant Medical Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Memorial Hospital Cancer Center
    • Denver, Colorado, United States, 80010
      • University of Colorado Cancer Center
    • Grand Junction, Colorado, United States, 81502
      • Saint Mary's Hospital and Medical Center
  • Delaware
    • Wilmington, Delaware, United States, 19899
      • CCOP - Christiana Care Health Services
  • District of Columbia
    • Washington, District of Columbia, United States, 20307-5000
      • Walter Reed Army Medical Center
  • Florida
    • Clearwater, Florida, United States, 33757-0210
      • Lykes Center for Radiation Therapy
    • Daytona Beach, Florida, United States, 32114
      • Halifax Medical Center
    • Fort Myers, Florida, United States, 33901
      • Radiation Therapy Associates - Fort Myers
    • Gainesville, Florida, United States, 32610-0296
      • University of Florida Health Science Center
    • Melbourne, Florida, United States, 32901
      • Health First Holmes Regional Medical Center
    • Miami, Florida, United States, 33136
      • Sylvester Cancer Center, University of Miami
    • Miami, Florida, United States, 33176-2197
      • Baptist Hospital of Miami
    • Miami, Florida, United States, 33125
      • Veterans Affairs Medical Center - Miami
    • Miami Beach, Florida, United States, 33140
      • CCOP - Mount Sinai Medical Center
    • Orange Park, Florida, United States, 32073
      • Florida Radiation Oncology Group
    • Orlando, Florida, United States, 32806
      • MD Anderson Cancer Center Orlando
    • Panama City, Florida, United States, 32405-4587
      • Gulf Coast Cancer Treatment Center
    • Panama City, Florida, United States, 32401
      • Bay Medical Center
    • Sarasota, Florida, United States, 34233
      • Sarasota Radiation and Medical Oncology Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial HealthCare
    • Tampa, Florida, United States, 33612-9497
      • H. Lee Moffitt Cancer Center and Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital - Atlanta
    • Atlanta, Georgia, United States, 30342-1701
      • CCOP - Atlanta Regional
    • Columbus, Georgia, United States, 31902
      • Medical Center/John B. Amos Community Cancer Center
    • Rome, Georgia, United States, 30165
      • InterCommunity Cancer Center at Rome
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • MBCCOP - Hawaii
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Community Hospital
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Cancer Research Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Decatur, Illinois, United States, 62526
      • CCOP - Central Illinois
    • Elgin, Illinois, United States, 60123
      • Provena St. Joseph Hospital- Regional Cancer Care Center
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Park Ridge, Illinois, United States, 60068
      • Lutheran General Cancer Care Center
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
  • Indiana
    • Anderson, Indiana, United States, 46016
      • St. John's Medical Center
    • Bloomington, Indiana, United States, 47402
      • Bloomington Hospital
    • Indianapolis, Indiana, United States, 46202
      • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    • Indianapolis, Indiana, United States, 46206-1367
      • Clarion Health Partners Inc.
    • Indianapolis, Indiana, United States, 46219
      • Community Hospitals of Indianapolis - Regional Cancer Center
    • Muncie, Indiana, United States, 47303-3499
      • Ball Memorial Hospital
    • South Bend, Indiana, United States, 46601
      • CCOP - Northern Indiana CR Consortium
  • Iowa
    • Dubuque, Iowa, United States, 52001
      • Wendt Regional Cancer Center of Finley Hospital
    • Iowa City, Iowa, United States, 52242-1009
      • Holden Comprehensive Cancer Center at the University of Iowa
  • Kentucky
    • Lexington, Kentucky, United States, 40511-1093
      • Veterans Affairs Medical Center - Lexington
    • Lexington, Kentucky, United States, 40536-0084
      • Albert B. Chandler Medical Center, University of Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center
    • Louisville, Kentucky, United States, 40215
      • Louisville Radiation Oncology
    • Madisonville, Kentucky, United States, 42431
      • Merle M. Mahr Cancer Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Cancer Center
    • Lafayette, Louisiana, United States, 70501
      • Romagosa Radiation Oncology Center
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
    • New Orleans, Louisiana, United States, 70121
      • CCOP - Ochsner
    • New Orleans, Louisiana, United States, 70112
      • MBCCOP - LSU Health Sciences Center
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Oncology Center
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore, Maryland, United States, 21225
      • Sinai Hospital of Baltimore
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center and Cancer Center
    • Baltimore, Maryland, United States, 21225
      • Harbor Hospital Center
    • Baltimore, Maryland, United States, 21237
      • Radiation Oncology Affiliates of Maryland, P.A.
    • Salisbury, Maryland, United States, 21801
      • Peninsula Regional Medical Center
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Hospital
    • Jamaica Plain, Massachusetts, United States, 02130
      • Veterans Affairs Medical Center - Boston (Jamaica Plain)
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0752
      • University of Michigan Comprehensive Cancer Center
    • Ann Arbor, Michigan, United States, 48106
      • CCOP - Ann Arbor Regional
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201-1379
      • Barbara Ann Karmanos Cancer Institute
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
    • Flint, Michigan, United States, 48432
      • McLaren Regional Cancer Center
    • Kalamazoo, Michigan, United States, 49007-3731
      • CCOP - Kalamazoo
    • Marquette, Michigan, United States, 49855
      • Marquette General Hospital
    • Midland, Michigan, United States, 48670
      • MidMichigan Medical Center - Midland
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Saginaw, Michigan, United States, 48601
      • St. Mary's Medical Center
    • Troy, Michigan, United States, 48098
      • William Beaumont Hospital - Troy
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center/Cancer Center
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center - Columbia
    • Kansas City, Missouri, United States, 64131
      • CCOP - Kansas City
    • Saint Louis, Missouri, United States, 63110-0250
      • St. Louis University Health Sciences Center
    • Saint Louis, Missouri, United States, 63110
      • Mallinckrodt Institute of Radiology
    • Springfield, Missouri, United States, 65807
      • CCOP - Cancer Research for the Ozarks
    • Springfield, Missouri, United States, 65807
      • Cancer Research for the Ozarks
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Cancer Center - Omaha
    • Omaha, Nebraska, United States, 68105-1018
      • Nebraska Health System
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Southern Nevada Cancer Research Foundation
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0002
      • Norris Cotton Cancer Center
    • Manchester, New Hampshire, United States, 03103
      • Elliot Regional Cancer Center
  • New Jersey
    • East Orange, New Jersey, United States, 07018-1095
      • Veterans Affairs Medical Center - East Orange
    • Edison, New Jersey, United States, 08818
      • John F. Kennedy Medical Center
    • Elizabeth, New Jersey, United States, 07201
      • Trinitas Hospital - Jersey Street Campus
    • Long Branch, New Jersey, United States, 07740-6395
      • Monmouth Medical Center
    • Millville, New Jersey, United States, 08332
      • South Jersey Regional Cancer Center
    • Mount Holly, New Jersey, United States, 08060
      • Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
    • New Brunswick, New Jersey, United States, 08901
      • Cancer Institute of New Jersey
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
    • Pomona, New Jersey, United States, 08240
      • Atlantic City Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital
    • Toms River, New Jersey, United States, 08755
      • Community Medical Center
    • Trenton, New Jersey, United States, 08629
      • St. Francis Medical Center
    • Warren, New Jersey, United States, 07059
      • Associated Radiologists, P.A.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Saint Joseph Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Cancer Center of Albany Medical Center
    • Bronx, New York, United States, 10461
      • Albert Einstein Comprehensive Cancer Center
    • Brooklyn, New York, United States, 11203
      • State University of New York Health Science Center at Brooklyn
    • Brooklyn, New York, United States, 11215-3609
      • New York Methodist Hospital
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute
    • Clifton Springs, New York, United States, 14432
      • Finger Lakes Radiation Oncology, P.C.
    • Manhasset, New York, United States, 11030
      • CCOP - North Shore University Hospital
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
    • New York, New York, United States, 10032
      • Herbert Irving Comprehensive Cancer Center
    • Plattsburgh, New York, United States, 12901
      • Champlain Valley Physicians Hospital Medical Center
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester Cancer Center
    • Syracuse, New York, United States, 13217
      • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • Valhalla, New York, United States, 10595
      • New York Medical College
    • Yonkers, New York, United States, 10701
      • Riverhill Radiation Oncology
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center, UNC
    • Concord, North Carolina, United States, 28025
      • Northeast Medical Center
    • Greenville, North Carolina, United States, 27858-4354
      • East Carolina University School of Medicine
    • Hickory, North Carolina, United States, 28601
      • Catawba Memorial Hospital
    • Winston-Salem, North Carolina, United States, 27104-4241
      • CCOP - Southeast Cancer Control Consortium
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Comprehensive Cancer Center at Wake Forest University
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Meritcare Roger Maris Cancer Center
    • Minot, North Dakota, United States, 58701
      • Trinity Cancer Care Center
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron General Medical Center
    • Akron, Ohio, United States, 44309
      • Akron City Hospital
    • Cincinnati, Ohio, United States, 45219
      • Barrett Cancer Center, The University Hospital
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Of Cleveland
    • Cleveland, Ohio, United States, 44106-5065
      • Ireland Cancer Center
    • Columbus, Ohio, United States, 43210-1240
      • Arthur G. James Cancer Hospital - Ohio State University
    • Columbus, Ohio, United States, 43206
      • CCOP - Columbus
    • Kettering, Ohio, United States, 45429
      • CCOP - Dayton
    • Toledo, Ohio, United States, 43623-3456
      • CCOP - Toledo Community Hospital Oncology Program
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Medical Center
    • Oklahoma City, Oklahoma, United States, 73101
      • St. Anthony Hospital
    • Tulsa, Oklahoma, United States, 74104
      • St. John Health System
  • Oregon
    • Portland, Oregon, United States, 97213
      • CCOP - Columbia River Program
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital Regional Cancer Center
    • Danville, Pennsylvania, United States, 17822-2001
      • Geisinger Medical Center
    • Darby, Pennsylvania, United States, 19023
      • Fitzgerald Mercy Hospital
    • Drexel Hill, Pennsylvania, United States, 19026
      • Delaware County Memorial Hospital
    • East Stroudsburg, Pennsylvania, United States, 18301
      • Pocono Cancer Center
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Geisinger Cancer Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Veterans Affairs Medical Center - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Cancer Center
    • Philadelphia, Pennsylvania, United States, 19102-1192
      • Hahnemann University Hospital
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • University of Pennsylvania Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107-5541
      • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15213-3489
      • University of Pittsburgh Cancer Institute
    • Pittsburgh, Pennsylvania, United States, 15219
      • Mercy Hospital of Pittsburgh
    • Reading, Pennsylvania, United States, 19612-6052
      • Reading Hospital and Medical Center
    • Scranton, Pennsylvania, United States, 18501
      • Mercy Hospital Cancer Center - Scranton
    • Sellersville, Pennsylvania, United States, 18960
      • Grand View Hospital
    • Wilkes-Barre, Pennsylvania, United States, 18764
      • Wilkes Barre General Hospital
    • Wynnewood, Pennsylvania, United States, 19096
      • CCOP - MainLine Health
    • York, Pennsylvania, United States, 17315
      • York Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02908-4735
      • Roger Williams Medical Center/BUSM
  • South Carolina
    • Charleston, South Carolina, United States, 29425-0721
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29615
      • CCOP - Greenville
    • Spartanburg, South Carolina, United States, 29303
      • CCOP - Upstate Carolina
  • South Dakota
    • Rapid City, South Dakota, United States, 57709
      • Rapid City Regional Hospital
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Jackson-Madison County General Hospital
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee, Memphis Cancer Center
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt-Ingram Cancer Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Harrington Cancer Center
    • Beaumont, Texas, United States, 77701
      • Julie and Ben Rogers Cancer Institute
    • Galveston, Texas, United States, 77555-0209
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030-4009
      • University of Texas - MD Anderson Cancer Center
    • Lackland Air Force Base, Texas, United States, 78236-5300
      • Wilford Hall - 59th Medical Wing
    • Lubbock, Texas, United States, 79410-1894
      • Joe Arrington Cancer Research and Treatment Center
    • Pasadena, Texas, United States, 77504
      • Bayshore Medical Center
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center - Cancer Institute
  • Utah
    • Saint George, Utah, United States, 84770
      • Dixie Regional Medical Center
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Sciences Center
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital
  • Vermont
    • Bennington, Vermont, United States, 05201
      • CCOP - Southwestern Vermont Regional Cancer Center
    • Burlington, Vermont, United States, 05401-3498
      • Vermont Cancer Center
    • Rutland, Vermont, United States, 05701
      • Green Mountain Oncology Group
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Martha Jefferson Hospital
    • Charlottesville, Virginia, United States, 22908
      • Cancer Center at the University of Virginia
    • Harrisonburg, Virginia, United States, 22801
      • RMH Regional Canter Center
    • Portsmouth, Virginia, United States, 23708-2197
      • Naval Medical Center, Portsmouth
    • Richmond, Virginia, United States, 23298-0037
      • Massey Cancer Center
    • Richmond, Virginia, United States, 23226
      • Bon-Secours - St. Mary's Hospital
  • Washington
    • Seattle, Washington, United States, 98111
      • Virginia Mason Medical Center
    • Spokane, Washington, United States, 99210-0248
      • Deaconess Medical Center
    • Yakima, Washington, United States, 98902
      • Yakima Valley Memorial Hospital
  • West Virginia
    • Wheeling, West Virginia, United States, 26003
      • Schiffler Cancer Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54307-3508
      • St. Vincent Hospital
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Foundation
    • Madison, Wisconsin, United States, 53792-6164
      • University of Wisconsin Comprehensive Cancer Center
    • Madison, Wisconsin, United States, 53713
      • Southern Wisconsin Radiotherapy Center
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic
    • Menomonee Falls, Wisconsin, United States, 53051
      • Community Memorial Hospital
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College Of Wisconsin
    • Milwaukee, Wisconsin, United States, 53210
      • St. Joseph's Hospital
    • Milwaukee, Wisconsin, United States, 53211
      • Columbia Hospital
    • Milwaukee, Wisconsin, United States, 53215
      • St. Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53295
      • Veterans Affairs Medical Center - Milwaukee (Zablocki)
    • Racine, Wisconsin, United States, 53405
      • Southeastern Wisconsin Regional Cancer Center
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell carcinoma of the lung Limited disease (stage I-IIIb but excluding T4 tumor based on malignant pleural effusion or N3 disease based on contralateral hilar or contralateral supraclavicular involvement) No pericardial or pleural effusion on chest x-ray regardless of cytology Measurable or evaluable disease Tumor must be encompassed by limited radiation therapy fields without causing severe symptomatic pulmonary dysfunction

PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Karnofsky 70-100% Life expectancy: Greater than 6 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No symptomatic heart disease At least 6 months since prior myocardial infarction Pulmonary: See Disease Characteristics Forced expiratory volume at one second (FEV1) greater than 0.8 L No uncontrolled bronchospasm in unaffected lung Other: No other serious concurrent illness No prior or concurrent malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other concurrent malignancy No history of uncontrolled psychiatric illness, severe head injury, chronic alcohol or drug abuse, or central nervous system disease Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No prior complete tumor resection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/D x 2 days, then BID x last 3 days.	Radiation: radiation therapy; Drug: etoposide; Drug: cisplatin
Experimental: Arm 2; Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/BID x last 5 days.	Radiation: radiation therapy; Drug: etoposide; Drug: cisplatin
Experimental: Arm 3; Large field radiation therapy 32.4 Gy, 1.8 Gy/fx/D/5 days x 18 fx, boost just in pm @ 1.8 Gy/fx on days 19 & 20, then boost 1.8 Gy BID x last 5 days.	Radiation: radiation therapy; Drug: etoposide; Drug: cisplatin
Experimental: Arm 4; Large field radiation therapy 28.8 Gy, 1.8 Gy/fx/5 days x 16 fx, boost just in pm @ 1.8 Gy/fx on days 17-20, then boost 1.8 Gy BID x last 5 days.	Radiation: radiation therapy; Drug: etoposide; Drug: cisplatin
Experimental: Arm 5; Large field radiation therapy 36 Gy, 1.8 Gy/fx/D 5 days/4 weeks, boost 1.8 Gy/D x 2 days, then BID x last 3 days.	Radiation: radiation therapy; Drug: etoposide; Drug: cisplatin
Experimental: Arm 6; Large field radiation therapy 25.2 Gy, 1.8 Gy/fx/5 days x 14 fx, boost just in pm @ 1.8 Gy/fx on days 15-20, then boost 1.8 Gy BID x last 5 days.	Radiation: radiation therapy; Drug: etoposide; Drug: cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of patients developing unacceptable (grade 3 or higher) acute toxicities attributable to thoracic irradiation with concurrent chemotherapy	From start of treatment until 90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare baseline and follow-up Mini Mental Status Examinations	From baseline until end of follow-up

Collaborators and Investigators

• Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Komaki R, Swann RS, Ettinger DS, Glisson BS, Sandler AB, Movsas B, Suh J, Byhardt RW. Phase I study of thoracic radiation dose escalation with concurrent chemotherapy for patients with limited small-cell lung cancer: Report of Radiation Therapy Oncology Group (RTOG) protocol 97-12. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):342-50. doi: 10.1016/j.ijrobp.2004.11.030.
• Komaki R, Swann S, Ettinger D, et al.: Phase I dose-escalation study of thoracic irradiation with concurrent chemotherapy for patients with limited small cell lung cancer (LSCLC). Radiation Therapy Oncology Group (RTOG) protocol 9712. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2539, 2003.

Study record dates

Study Major Dates

• Study Start: February 1, 1998
• Primary Completion (Actual): October 1, 2002
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: April 6, 2000
• First Submitted That Met QC Criteria: January 28, 2004
• First Posted (Estimate): January 29, 2004

Study Record Updates

• Last Update Posted (Estimate): November 3, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: limited stage small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide
• Other Study ID Numbers: RTOG-9712; CDR0000065797