Clinical trial NCT00003317: Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: stage IIIA non-small cell lung cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-24
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy for stage IIIA non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have stage IIIA non-small cell lung cancer that has been surgically removed.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Overall survival
timeFrame: Up to 5 years
measure: Disease-free survival
timeFrame: Up to 5 years
measure: Patterns of local and distant recurrence in these patients
timeFrame: Up to 5 years
measure: Toxicities associated with chemotherapy with or without adjuvant radiotherapy in patients.
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CCOP - Scottsdale Oncology Program
state: Arizona
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology
state: Iowa
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Duluth
country: United States
facility: CCOP - Duluth
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Bismarck
country: United States
facility: Quain & Ramstad Clinic, P.C.
state: North Dakota
city: Fargo
country: United States
facility: CCOP - Merit Care Hospital
state: North Dakota
city: Grand Forks
country: United States
facility: Altru Health Systems
state: North Dakota
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital Oncology Program
state: Ohio
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Leslie J. Kohman, MD
role: STUDY_CHAIR
References:
citation: Perry MC, Kohman L, Bonner J, et al.: Updated analysis of a phase III study of surgical resection and chemotherapy (paclitaxel/carboplatin) (CT) with or without adjuvant radiation therapy (RT) for resected stage III non-small cell lung cancer (NSCLC) CALGB 9734. [Abstract] J Clin Oncol 23 (Suppl 16): A-7145, 656s, 2005.
citation: Perry MC, Kohman LJ, Bonner JA, Gu L, Wang X, Vokes EE, Green MR. A phase III study of surgical resection and paclitaxel/carboplatin chemotherapy with or without adjuvant radiation therapy for resected stage III non-small-cell lung cancer: Cancer and Leukemia Group B 9734. Clin Lung Cancer. 2007 Jan;8(4):268-72. doi: 10.3816/CLC.2007.n.005.