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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
N/A
Not Enrolling
Both
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
patients.

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
Characteristics

Type of Study:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CDR0000066266

NCT ID:

NCT00003317

Start Date:

May 1998

Completion Date:

Related Keywords:

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

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080