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A Phase III Study of Surgical Resection and Chemotherapy (Paclitaxel and Carboplatin) With or Without Adjuvant Radiotherapy for Resected Stage IIIA Non-Small Cell Lung Cancer

Phase 3
18 Years
Not Enrolling
Lung Cancer

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Trial Information

A Phase III Study of Surgical Resection and Chemotherapy (Paclitaxel and Carboplatin) With or Without Adjuvant Radiotherapy for Resected Stage IIIA Non-Small Cell Lung Cancer

OBJECTIVES: I. Compare the overall survival of surgically resected patients with limited
stage IIIA non-small cell lung cancer who are treated by postoperative chemotherapy with or
without adjuvant radiotherapy. II. Compare failure free survival of these patients. III.
Describe the patterns of local and distant recurrence in these patients. IV. Determine the
toxicities associated with chemotherapy with or without adjuvant radiotherapy in these

OUTLINE: This is a randomized, multicenter study. Four to eight weeks after surgery, all
patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on
days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are
randomized into one of two treatment arms. Arm I: Patients receive no further therapy. Arm
II: Patients receive radiotherapy 5 days a week for 5 weeks to the mediastinum, beginning
2.5 to 4 weeks after completion of chemotherapy. Patients are followed at least every 4
months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 480 patients will be accrued for this study over 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage IIIA non-small cell lung cancer
that has been completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve
lobectomy through any incision (thoracoscopic or video assisted resection is acceptable)
No known residual disease present Involvement in N2 nodes must have been determined only
at the time of surgical exploration or by postoperative pathologic diagnosis All grossly
involved nodes must be removed at surgery No positive mediastinoscopy (if lymph nodes on
CT scan are greater than 1.5 cm in diameter, mediastinoscopy is required)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ZUBROD 0-1 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT no greater than upper limit of
normal Renal: Creatinine clearance at least 20 mL/min Other: Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent growth factors Chemotherapy: No
prior chemotherapy for non-small cell lung cancer No other concurrent chemotherapy
Endocrine therapy: No concurrent hormone therapy except: Steroids for adrenal failure
Hormones for nondisease related conditions Dexamethasone as an antiemetic Radiation
therapy: No prior radiotherapy for non-small cell lung cancer Surgery: See Disease

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Leslie J. Kohman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

State University of New York - Upstate Medical University


United States: Federal Government

Study ID:




Start Date:

May 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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