Cisplatin, Etoposide, and Two Different Schedules of Radiation Therapy in Treating Patients With Limited Stage Small Cell Lung Cancer

Official Title

A 2-Arm Randomized Controlled Trial of Concurrent Chemo-Radiotherapy Comparing Twice-Daily and Once-Daily Radiation Therapy Schedules in Patients With Limited Stage Small Cell Lung Cancer (SCLC) and Good Performance Status [CONVERT]

Summary:

RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumour cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumour cells. It is not yet known which schedule of radiation therapy is more effective when given together with chemotherapy in treating small cell lung cancer. PURPOSE: This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer.

Trial Description

Primary Outcome:

• Overall survival

Secondary Outcome:

• Local progression-free survival
• Metastasis-free survival
• Toxicity
• Response rate
• Cytotoxic dose intensity
• Radiotherapy dose intensity

OBJECTIVES:
Primary

• Compare overall survival of patients with limited stage small cell lung cancer treated with chemoradiotherapy comprising cisplatin, etoposide, and once vs twice daily radiation therapy.
  

Secondary

• Compare local progression-free survival of patients treated with these regimens.

• Compare metastasis-free survival of patients treated with these regimens.

• Compare the toxicity of these regimens in these patients.

• Compare response rates in patients treated with these regimens.

• Compare the cytotoxic dose intensity of these regimens in these patients.

• Compare the dose intensity of two different schedules of radiation therapy in these patients.

OUTLINE:

This is a multicentre, randomized, controlled study. Patients are stratified according to participating centre, ECOG performance status (0-1 vs 2), and lactic dehydrogenase, sodium, and alkaline phosphatase levels. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive cisplatin IV over 2 hours on days 1-3 OR on day 1 only and etoposide IV over 45-90 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses. During course 2, patients undergo concurrent radiation therapy once daily 5 days a week for 6½ weeks (total of 33 fractions).

• Arm II: Patients receive cisplatin and etoposide as in arm I. During courses 2 and 3, patients undergo concurrent radiation therapy twice daily 5 days a week for 3 weeks (total of 30 fractions). In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 3-4 weeks after completion of chemoradiotherapy, patients in both arms achieving a complete or partial response with no evidence of brain metastasis undergo prophylactic cranial irradiation once daily 5 days a week for 2 weeks (total of 10 fractions). After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
  

View this trial on ClinicalTrials.gov