Lung Cancer Clinical Trial
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
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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