Phase II Trial of Concurrent Paclitaxel, Carboplatin and External Beam Radiotherapy Followed by Surgical Resection in Stage IIIA (N2) Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase II Trial of Concurrent Paclitaxel, Carboplatin and External Beam Radiotherapy Followed by Surgical Resection in Stage IIIA (N2) Non-Small Cell Lung Cancer
OBJECTIVES:
- Determine the response rate, duration of response, and survival in patients with bulky
stage IIB or stage IIIA non-small cell lung cancer treated with paclitaxel,
carboplatin, and radiotherapy followed by surgical resection.
- Assess the toxicity of this regimen in this patient population.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 5
weeks. Patients also undergo concurrent radiotherapy daily 5 days a week for 5 weeks in the
absence of unacceptable toxicity. At approximately 4 weeks after completion of
chemoradiotherapy, patients with stable or regressive disease undergo surgical resection. If
disease is unresectable, patients receive an additional 2 weeks of radiotherapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 29-30 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed bulky stage IIB or stage IIIA non-small cell lung cancer
- Ipsilateral mediastinal node involvement by mediastinoscopy
- No contralateral lymph node involvement
- No malignant pleural effusion
- No distant metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- ALT/AST less than 2 times upper limit of normal
- Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior malignancy within the past 5 years except adequately treated carcinoma
in situ of the cervix or nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Pathologic response rate as measured by pathology of the resected specimen and chest x-ray at 3 and 5 years after completion of study treatment
Safety Issue:
No
Principal Investigator
David J. Perry, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Washington Hospital Center
Authority:
United States: Federal Government
Study ID:
CDR0000068288
NCT ID:
NCT00006469
Start Date:
August 1999
Completion Date:
Related Keywords:
- Lung Cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
| Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore, Maryland 21237 |
