Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer

Phase 3

• Conditions: Lung Cancer

• Registration Number: NCT00077220
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectable stage II or stage III non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying giving paclitaxel, carboplatin, and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

* Compare the progression-free survival of patients with stage II or III unresectable non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy with or without adjuvant paclitaxel and carboplatin.

Secondary

* Compare the objective response rate in patients treated with these regimens.

* Compare the overall survival of patients treated with these regimens.

* Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to radiotherapy regimen (conformational vs nonconformational).

Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for up to 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 7-7.5 weeks. Three weeks after completion of chemoradiotherapy, patients with stable or responding disease are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo routine follow-up.

* Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a maximum of 3 courses.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 390 patients will be accrued for this study within 3 years.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2004-02-10
• Study First Submitted QC: 2004-02-10
• Study First Posted: 2004-02-11
• Status Verified: 2007-05
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival

Secondary Outcome Measures

Name	Time	Method
Toxicity
Objective response rate
Overall survival

Trial Locations

Locations (67)

Centre Hospitalier d'Annecy; 🇫🇷 Annecy, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Hopital Duffaut; 🇫🇷 Avignon, France

Centre Hospitalier Bayeux; 🇫🇷 Bayeux, France

Centre Hospitalier de la Cote Basque; 🇫🇷 Bayonne, France

C.H.G. Beauvais; 🇫🇷 Beauvais, France

Hopital Avicenne; 🇫🇷 Bobigny, France

Clinique du Cedre; 🇫🇷 Bois-Guillaume, France

Hopital Saint Andre; 🇫🇷 Bordeaux, France

Clinique Tivoli; 🇫🇷 Bordeaux, France

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