Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments carboplatin, paclitaxel, adjuvant therapy, radiation therapy
Phase phase 3
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date June 2002
Trial identifier NCT00077220, CDR0000350015, EU-20330, FRE-GERCOR-B00-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Measure
Progression-free survival
time frame:

Secondary Outcomes

Measure
Objective response rate
time frame:
Overall survival
time frame:
Toxicity
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer - Stage II or III disease - Not amenable to surgery - Measurable or evaluable disease - No T4 apical localization - Lesions able to be covered in a 60 Gy minimum volume of radiation - No pleural effusion PATIENT CHARACTERISTICS: Age - 18 to 79 Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count > 1,500/mm^3 - Platelet count > 100,000/mm^3 Hepatic - Bilirubin < 1.5 times upper limit of normal (ULN) Renal - Creatinine < 1.25 times ULN Cardiovascular - No unstable heart disease Pulmonary - No ventilation dysfunction that would preclude radiotherapy Other - No weight loss of 15% or more within the past 2 months - No uncontrolled infection - No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 6 months since prior neoadjuvant chemotherapy - No prior adjuvant chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy Surgery - Not specified Other - No other concurrent clinical trial participation

Additional Information

Official title Phase III Randomised Study Of Adjuvant Paclitaxel And Carboplatin (TAXOL-PARAPLATINE) With Concomittant Radiotherapy In Patients With Stage II or III Non-Metastatic Non-Small Cell Lung Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).