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A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER


Phase 3
18 Years
75 Years
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER


OBJECTIVES: I. Compare the impact on overall survival of adjuvant cisplatin and either a
vinca alkaloid or etoposide (with or without radiotherapy) vs. no adjuvant chemotherapy in
patients with completely resected stage I/II/III non-small cell lung cancer. II. Assess the
frequency of treatment-related deaths and severe toxic effects. III. Describe the patterns
of failure, second malignancies, and toxic effects associated with each treatment regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
institution, type of prior surgery, and pathologic stage. Each participating center will
determine which combination chemotherapy regimen and which of three cisplatin doses will be
given to all patients treated at that center. The treatment group receives cisplatin
combined with either vindesine, vinblastine, vinorelbine, or etoposide every 3-4 weeks for
3-4 courses, depending on the dose of cisplatin. The second group receives no adjuvant
chemotherapy. Treating institutions determine prior to entering the trial which patients
receive adjuvant radiotherapy: none; those with node-positive disease; those with N1 disease
only; those with N2 disease only; or those eligible for a randomized radiotherapy trial. For
patients in the treatment group, radiotherapy begins 3-4 weeks after the last course.
Patients are followed at 6 months, then annually.

PROJECTED ACCRUAL: A maximum of 3,300 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically documented non-small cell lung cancer Any
non-small cell histology eligible Pathologic stage I/II/III disease that is completely
resected with microscopically clear margins within 60 days of entry (30 days preferred)

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: Not specified Hematopoietic:
Not specified Hepatic: Not specified Renal: Not specified Other: No clear contraindication
to chemotherapy No second malignancy except: Nonmelanomatous skin cancer Carcinoma in situ
of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic radiotherapy
Surgery: Complete resection required prior to entry

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Thierry L. Le Chevalier, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

United States: Federal Government

Study ID:

CDR0000065002

NCT ID:

NCT00002823

Start Date:

February 1995

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage III non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Comprehensive Cancer Center at JFK Medical CenterAtlantis, Florida  33462