Title
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 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
Phase
Phase 3Study Type
InterventionalStatus
Unknown statusIndication/Condition
Lung CancerIntervention/Treatment
paclitaxel carboplatin ...Study Participants
NoneRATIONALE: 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.
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
