Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-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. Drugs such as efaproxiral may make the tumor cells more sensitive to radiation therapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without efaproxiral in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy combined with radiation therapy with or without efaproxiral in treating patients who have stage III non-small cell lung cancer.
Drug: gemcitabine hydrochloride
Drug: vinorelbine ditartrate
Procedure: radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||November 2002|
- 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 efaproxiral.
- 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 regimens:
- 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 thereafter.
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.
|United States, Arizona|
|St. Joseph's Hospital and Medical Center|
|Phoenix, Arizona, United States, 85013|
|United States, Idaho|
|North Idaho Cancer Center|
|Coeur d'Alene, Idaho, United States, 83814|
|United States, Kentucky|
|Cancer Center at Lexington Clinic|
|Lexington, Kentucky, United States, 40504|
|United States, Louisiana|
|Willis - Knighton Cancer Center|
|Shreveport, Louisiana, United States, 71103-3951|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|St. Agnes Cancer Center|
|Baltimore, Maryland, United States, 21229|
|United States, Washington|
|Providence Everett Medical Center - Pacific Campus|
|Everett, Washington, United States, 98206|
|United States, West Virginia|
|Schiffler Cancer Center|
|Wheeling, West Virginia, United States, 26003|
|Algemeen Ziekenhuis Middelheim|
|Antwerp, Belgium, 2020|
|Tom Baker Cancer Center - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Regional Cancer Centre|
|Ottawa, Ontario, Canada, K1H 1C4|
|Fleurimont, Quebec, Canada, J1H 5N4|
|Montreal, Quebec, Canada, H2W 1S6|
|Hopital Notre- Dame du CHUM|
|Montreal, Quebec, Canada, H2L 4M1|
|Montreal, Quebec, Canada, H1T 2M4|
|Centre Hospitalier Universitaire de Quebec|
|Quebec City, Quebec, Canada, G1R 2J6|
|Soroka University Medical Center|
|Beer-Sheva, Israel, 84101|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Sheba Medical Center|
|Tel Hashomer, Israel, 52621|
|Tel-Aviv Sourasky Medical Center|
|Tel-Aviv, Israel, 64239|
|Study Chair:||Hak Choy, MD||Simmons Cancer Center|