A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Patients With Locally Advanced Unresectable (Stage IIIA/IIIB) Non-Small Cell Lung Cancer
- Compare the overall survival of patients with stage IIIA or IIIB non-small cell lung
cancer treated with induction chemotherapy followed by radiotherapy with or without
- Compare time to progression, response rate, and pattern of failure of patients treated
with these regimens.
- Determine the safety of efaproxiral in these patients.
- Determine the pharmacokinetics of efaproxiral in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to chemotherapy regimen, Karnofsky performance status (70-80% vs 90-100%), and
disease stage (IIIA vs IIIB).
- Induction therapy phase: Patients receive 1 of the following induction chemotherapy
- Paclitaxel and carboplatin: Patients receive paclitaxel IV and carboplatin IV on
day 1. Treatment repeats every 21 days for a total of 2 courses.
- Cisplatin and gemcitabine: Patients receive cisplatin IV on day 2 and gemcitabine
IV on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.
- Cisplatin and vinorelbine: Patients receive cisplatin IV on day 1 and vinorelbine
IV on days 1, 8, and either 15 or 22. Treatment repeats every 28 days for a total
of 2 courses.
- Randomized phase: Within 42 days after completion of chemotherapy, patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive efaproxiral IV over 30-45 minutes with supplemental oxygen
and then undergo concurrent radiotherapy 5 days a week for 7 weeks.
- Arm II: Patients receive supplemental oxygen and undergo radiotherapy as in arm I.
Quality of life is assessed at baseline, on days 1 and 16 of radiotherapy, monthly for 3
months, every 3 months for 2 years, every 6 months for 3 years, and then annually
Patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3
years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 659 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Hak Choy, MD
Simmons Cancer Center
United States: Federal Government
|St. Joseph's Hospital and Medical Center||Phoenix, Arizona 85001-2071|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Schiffler Cancer Center||Wheeling, West Virginia 26003|
|North Idaho Cancer Center||Coeur d'Alene, Idaho 83814|
|Cancer Center at Lexington Clinic||Lexington, Kentucky 40504|
|St. Agnes Cancer Center||Baltimore, Maryland 21229|
|Willis - Knighton Cancer Center||Shreveport, Louisiana 71103-3951|
|Providence Everett Medical Center - Pacific Campus||Everett, Washington 98206|