Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage 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: This phase II trial is studying how well giving cisplatin and etoposide together with radiation therapy works in treating patients with limited-stage small cell lung cancer.
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer|
- Overall survival at 2 years [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. ] [ Designated as safety issue: No ]
- Overall survival at 1 year and median overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year. ] [ Designated as safety issue: No ]
- Progression-free survival at 1 year and median survival time [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year. ] [ Designated as safety issue: No ]
- Rate of acute treatment related Grade 3 or 4 esophagitis [ Time Frame: From start of radiation therapy until 90 days following the start of radiation therapy ] [ Designated as safety issue: Yes ]
- Rate of treatment related fatalities at 2 years [ Time Frame: From the start of treatment to 2 years ] [ Designated as safety issue: Yes ]
- Response rates (complete response, partial response, progressive disease and stable disease) [ Time Frame: From the start of treatment to 2 months following the completion of chemotherapy ] [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Study Completion Date:||November 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Accelerated high dose irradiation and chemotherapy
Accelerated high dose thoracic irradiation with concurrent etoposide and cisplatin
|Drug: cisplatin Drug: etoposide Procedure: adjuvant therapy Radiation: radiation therapy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066222
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|Study Chair:||Ritsuko U. Komaki, MD, FACR||M.D. Anderson Cancer Center|