A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer
Both
Lung Cancer
Trial Information
A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer
OBJECTIVES:
- Determine the response rate of patients with limited stage small cell lung cancer
treated with cisplatin and etoposide combined with accelerated high-dose thoracic
radiotherapy.
- Determine the progression-free and overall survival in patients treated with this
regimen.
- Determine the qualitative and quantitative toxicity and reversibility of toxicity of
this regimen in these patients.
OUTLINE: Patients undergo radiotherapy once daily 5 days a week for approximately 3 weeks
and then twice daily 5 days a week for approximately 2 weeks (a total of 9 treatment days
during the final 2-week treatment period). Beginning on the first day of radiotherapy,
patients receive cisplatin IV over 2 hours and etoposide IV over 1 hour on day 1 and oral
etoposide once daily on days 2 and 3. Chemotherapy repeats every 3 weeks for up to 4 courses
in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 18 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell carcinoma of the lung by fine
needle aspiration biopsy or two positive sputa
- Must have limited disease
- Stage I, II, IIIA, or IIIB
- Confined to 1 hemithorax, but excluding the following:
- T4 tumor based on malignant pleural effusion
- N3 disease based on contralateral hilar or supraclavicular involvement
- No pericardial or pleural effusions on chest x-ray (regardless of cytology)
- Measurable or evaluable disease
- Tumor must be able to be encompassed by limited radiotherapy fields without
significantly compromising pulmonary function
- No prior complete tumor resection
PATIENT CHARACTERISTICS:
Age
- 18 to 100
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 150,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- No myocardial infarction within the past 6 months
- No symptomatic heart disease
Pulmonary
- No chronic obstructive pulmonary disease with FEV_1 no greater than 0.8 liter
- No uncontrolled bronchospasm in the unaffected lung
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Available for follow-up
- No other malignancy within the past 2 years except curatively treated basal cell or
squamous cell skin cancer or non-invasive in situ malignancies
- No other concurrent serious medical illness
- No uncontrolled psychiatric illness
- No chronic alcohol or drug abuse
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the chest or other area containing a large amount of bone
marrow (e.g., more than 75% of pelvic bone)
Surgery
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival at 1 and 2 years
Safety Issue:
No
Principal Investigator
Ritsuko U. Komaki, MD, FACR
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000271939
NCT ID:
NCT00066222
Start Date:
June 2003
Completion Date:
Related Keywords:
- Lung Cancer
- limited stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Foote Hospital | Jackson, Michigan 49201 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
| St. Agnes Cancer Center | Baltimore, Maryland 21229 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Cottonwood Hospital Medical Center | Murray, Utah 84107 |
| McKay-Dee Hospital Center | Ogden, Utah 84403 |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
| Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
| Eden Medical Center | Castro Valley, California 94546 |
| Saint Rose Hospital | Hayward, California 94545 |
| Highland General Hospital at St. George's University School of Medicine | Oakland, California 94602 |
| Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
| Valley Care Medical Center | Pleasanton, California 94588 |
| J.C. Robinson, M.D. Regional Cancer Center | San Pablo, California 94806 |
| St. Joseph Medical Center | Bloomington, Illinois 61701 |
| Graham Hospital | Canton, Illinois 61520 |
| Memorial Hospital | Carthage, Illinois 62321 |
| Eureka Community Hospital | Eureka, Illinois 61530 |
| Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
| Galesburg Clinic | Galesburg, Illinois 61401 |
| Mason District Hospital | Havana, Illinois 62644 |
| Kewanee Hospital | Kewanee, Illinois 61443 |
| McDonough District Hospital | Macomb, Illinois 61455 |
| BroMenn Regional Medical Center | Normal, Illinois 61761 |
| Community Cancer Center | Normal, Illinois 61761 |
| Community Hospital of Ottawa | Ottawa, Illinois 61350 |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
| Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
| OSF St. Francis Medical Center | Peoria, Illinois 61637 |
| Illinois Valley Community Hospital | Peru, Illinois 61354 |
| Perry Memorial Hospital | Princeton, Illinois 61356 |
| St. Margaret's Hospital | Spring Valley, Illinois 61362 |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
| Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana 46904 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
| Fox Chase Cancer Center at St. Francis Medical Center | Trenton, New Jersey 08629 |
| Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
| Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
| Grandview Hospital | Dayton, Ohio 45405 |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
| Good Samaritan Hospital | Dayton, Ohio 45406 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
| Middletown Regional Hospital | Middletown, Ohio 45044 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
| Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
| Wendt Regional Cancer Center at Finley Hospital | Dubuque, Iowa 52001 |
| Cancer Treatment Center at the Medical Center - Bowling Green | Bowling Green, Kentucky 42101 |
| South Jersey Healthcare Regional Cancer Center | Millville, New Jersey 08332 |
| Huron Hospital Cancer Care Center | Cleveland, Ohio 44112 |
| Euclid Hospital | Cleveland, Ohio 44119 |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
| South Pointe Hospital Cancer Care Center | Warrensville Heights, Ohio 44122 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
| Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
| Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona, California 91767 |
| Wilmed Radiation Oncology Services | Wilson, North Carolina 27893 |
| Columbia St. Mary's Cancer Care Center | Milwaukee, Wisconsin 53211 |
| J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
| Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York 12901 |
