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
18 Years
79 Years
Both
Lung Cancer
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Safety Issue:
No
Principal Investigator
Jean F. Morere, MD
Investigator Affiliation:
Hopital Avicenne
Authority:
United States: Federal Government
Study ID:
CDR0000350015
NCT ID:
NCT00077220
Start Date:
June 2002
Completion Date:
Related Keywords:
- Lung Cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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