NCT00433563

Concurrent Once Daily Versus Twice Daily Radiotherapy for Limited Stage Small Cell Lung Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 547 (actual)
• Sponsor: The Christie NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor 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.

Detailed description

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 radiotherapy. 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 radiotherapy in these patients. OUTLINE: This is a multicenter, randomized, controlled study. Patients are stratified according to participating center, 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 radiotherapy 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 radiotherapy 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. PROJECTED ACCRUAL: A total of 532 patients will be accrued for this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	Once daily radiotherapy	Standard of care chemotherapy (cisplatin/etoposide) + once daily radiotherapy
RADIATION	Twice daily radiotherapy	Standard of care chemotherapy (cisplatin/etoposide) + twice daily radiotherapy

Timeline

• Start date: 2008-04-01
• Primary completion: 2016-02-01
• Completion: 2019-01-01
• First posted: 2007-02-12
• Last updated: 2022-09-08

Locations

1 site across 1 country: United Kingdom