Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00005022
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 cisplatin 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. Arm 1 etoposide 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. Arm 1 radiation therapy 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. Arm 2 cisplatin Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/BID x last 5 days. Arm 2 etoposide Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/BID x last 5 days. Arm 2 radiation therapy Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/BID x last 5 days. Arm 3 cisplatin 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. Arm 4 etoposide 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. Arm 3 etoposide 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. Arm 3 radiation therapy 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. Arm 4 cisplatin 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. Arm 5 etoposide 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. Arm 5 radiation therapy 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. Arm 6 etoposide 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. Arm 6 radiation therapy 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. Arm 4 radiation therapy 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. Arm 5 cisplatin 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. Arm 6 cisplatin 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Compare baseline and follow-up Mini Mental Status Examinations From baseline until end of follow-up
Trial Locations
- Locations (262)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
🇺🇸Tuscallosa, Alabama, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
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