NCT00253591

Radiation Therapy With or Without Vinorelbine and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Randomised Phase II/III Trial of Induction Chemotherapy Followed by Continuous Hyperfractionated Accelerated Radiotherapy (CHART) Versus CHART Alone in Patients With Inoperable Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as vinorelbine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with vinorelbine and cisplatin is more effective than radiation therapy alone in treating non-small cell lung cancer. PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy together with vinorelbine and cisplatin works and compares it to radiation therapy alone in treating patients with stage I, stage II, or stage III non-small cell lung cancer.

Detailed description

OBJECTIVES: Primary * Compare the overall survival of patients with stage I-III non-small cell lung cancer treated with vinorelbine, cisplatin, and continuous hyperfractionated accelerated radiotherapy (CHART) vs CHART alone. Secondary * Compare the response, progression-free survival, and quality of life of patients treated with these regimens. * Compare the toxic effect of these regimens in these patients. * Compare the cost effectiveness of these regimens in these patients. * Compare the local and distant control in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo continuous hyperfractionated accelerated radiotherapy (CHART) 3 times a day for 12 consecutive days. * Arm II: Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks later, patients undergo CHART as in arm I. Quality of life is assessed periodically. After completion of study treatment, patients are evaluated periodically for at least 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	vinorelbine tartrate
RADIATION	radiation therapy

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-12-01
• Completion: 2009-12-01
• First posted: 2005-11-15
• Last updated: 2013-12-19

Locations

20 sites across 1 country: United Kingdom