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.
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 ]Survival time is defined as time from study registration to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 2 years. This study was designed to detect an improvement in the 2-year overall survival rate from 47% to 60%. Using a one-group chi-square test with a one-sided significance level of 0.10, a sample of 67 patients was deemed sufficient to detect the difference between the null hypothesis (Ho: P .47) and the alternative hypothesis (Ha: P .60) with 80% power.
- 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: Radiation Therapy + Chemotherapy
Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
60 mg/m2 given intravenously. During RT, give on day 1 and day 22. After completion of RT, on days 43 and 64.Drug: Etoposide
120 mg/m2 given intravenously. During RT, give on days 1-3, then days 22-24. After completion of RT, on days 43-45 and days 64-66.Radiation: Radiation therapy
Large field 28.8 Gy: 1.8 Gy per fraction, 5 days per week for 16 fractions. On days 23-26, BID: use anteroposterior and posteroanterior (AP/PA) fields in a.m. at 1.8 Gy per fraction; boost with 2nd treatment in p.m. at 1.8 Gy per fraction. Then off-cord boost, 1.8 Gy, BID, x last 5 days for a total dose of 61.2 Gy in 5 wks.
- 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|