Phase III Randomized Study of Paclitaxel and Carboplatin or Cisplatin Followed by Radiotherapy With or Without Concurrent Paclitaxel in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
18 Years
70 Years
Both
Lung Cancer
Trial Information
Phase III Randomized Study of Paclitaxel and Carboplatin or Cisplatin Followed by Radiotherapy With or Without Concurrent Paclitaxel in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
OBJECTIVES:
- Compare the overall survival rate of patients with unresectable stage III non-small
cell lung cancer treated with paclitaxel and carboplatin or cisplatin followed by
radiotherapy with or without concurrent paclitaxel.
- Compare the 1-year survival rate and mean survival time in patients treated with these
regimens.
- Compare the objective response rate and local control in patients treated with these
regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the safety profile and toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes
or cisplatin IV on day 1. Treatment repeats every 21 days for 2 courses. Patients then
proceed to randomized treatment.
- Arm I: Patients receive paclitaxel IV over 1 hour on day 1 and radiotherapy on days 1-5
of each week for 6 weeks.
- Arm II: Patients receive radiotherapy 5 days a week for 7 weeks. Patients are followed
every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this
study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage III non-small cell lung cancer
(NSCLC)
- Locoregionally advanced unresectable disease
- Previously untreated
- Measurable disease
- No involvement of supraclavicular lymph nodes
- No cytologically positive pleural or pericardial effusion
- No invasion to the wall of the esophagus or the cardiac ventricle
- No bone marrow involvement
- No distant metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Performance status:
- WHO 0-1
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC greater than 4,000/mm^3
- Absolute neutrophil count greater than 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic:
- Bilirubin less than upper limit of normal (ULN)
- AST and ALT less than 2.5 times ULN
- Alkaline phosphatase less than 5 times ULN
- No hepatic abnormalities
Renal:
- Creatinine less than ULN
Cardiovascular:
- No myocardial infarction within the past 6 months
- No cardiac insufficiency
- No uncontrolled arrhythmia
Pulmonary:
- FEV1 greater than 1 L
- DLCO at least 30% predicted
- No pneumonia
- No other non-disease-related pulmonary complications
Other:
- No more than 10% of total weight loss over the past 6 months
- No other disease that would preclude study
- No peripheral neuropathy grade 3 or greater
- No other prior or concurrent malignancy except curatively treated nonmelanoma skin
cancer or carcinoma in situ of the cervix
- No familial, geographic, or psychological condition that would preclude study
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy
- No concurrent immunotherapy
Chemotherapy:
- No prior systemic chemotherapy
Endocrine therapy:
- No concurrent endocrine therapy
Radiotherapy:
- No prior radiotherapy for NSCLC
Surgery:
- See Disease Characteristics
- No prior complete resection of tumor
- Prior radical surgical resection allowed if local recurrence of disease
- No concurrent major surgery
Other:
- No other concurrent anticancer therapy or investigational agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Overall survival rate
Safety Issue:
No
Principal Investigator
Paolo Bruzzi, MD, MPH, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
National Institute for Cancer Research, Italy
Authority:
United States: Federal Government
Study ID:
CDR0000068846
NCT ID:
NCT00039039
Start Date:
February 2000
Completion Date:
Related Keywords:
- Lung Cancer
- recurrent 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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