SWOG-9416: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy using cisplatin and etoposide, radiation therapy, and surgery, with adjuvant therapy using cisplatin and etoposide, in treating patients who have stage III non-small cell lung cancer.
Procedure: conventional surgery
Radiation: low-LET cobalt-60 gamma ray therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Induction Chemoradiotherapy Followed by Surgical Resection for Non-small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors): A Phase II Trial|
- Feasibility [ Time Frame: 9-12 weeks after study entry ] [ Designated as safety issue: No ]resectibility rate
- toxicity [ Time Frame: 16-20 weeks ] [ Designated as safety issue: Yes ]Toxicity assessments per Southwest Oncology Group toxicity criteria
- response rate [ Time Frame: 16-20 weeks after registration ] [ Designated as safety issue: No ]Greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of disease. No new lesions.
|Study Start Date:||April 1995|
|Study Completion Date:||July 2004|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
Experimental: chemoradiotherapy followed by surgery
chemoradiotherapy followed by surgery and post-surgery boost chemotherapy
50 mg/m2, IV Days 1 and 8, two 28 day cycles prior to surgery and two 28 day cycles after surgery
Other Name: platinolDrug: etoposide
50 mg/m2, IV Days 1-5, two 28 day cycles prior to surgery and two 28 day cycles after surgery
Other Name: VP-16Procedure: conventional surgery
surgery some time between weeks 9 and 12
Other Name: surgeryRadiation: low-LET cobalt-60 gamma ray therapy
180 cGy per day, Days 1-5, weekly for 5 weeks
Other Name: RT
OBJECTIVES: I. Assess the feasibility and toxic effects of 2 courses of cisplatin/etoposide given concurrently with continuous, fractionated chest irradiation followed by surgical resection and boost chemotherapy in patients with Pancoast tumors without mediastinal or supraclavicular nodal involvement. II. Assess the objective response rate, resectability rate, and proportion of patients free of microscopic residual disease after such treatment.
OUTLINE: All patients receive Induction on Regimen A and, in the absence of progression, proceed to Regimen B, then C. Patients who refuse or are medically unfit for surgery following Regimen A proceed directly to Regimen C. Regimen A: 2-Drug Combination Chemotherapy plus Radiotherapy. Cisplatin, CDDP, NSC-119875; Etoposide, VP-16, NSC-141540; plus irradiation of the tumor and ipsilateral supraclavicular region using megavoltage equipment (photons with peak energies of 4-15 MV). Regimen B: Surgery. Tumor resection. Regimen C: 2-Drug Combination Chemotherapy. CDDP; VP-16.
PROJECTED ACCRUAL: 99 patients will be accrued over 2-4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002642
|United States, Tennessee|
|Vanderbilt Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Study Chair:||Valerie W. Rusch, MD, FACS||Memorial Sloan-Kettering Cancer Center|
|Study Chair:||David H. Johnson, MD||Vanderbilt-Ingram Cancer Center|
|Study Chair:||Lawrence N. Shulman, MD||Dana-Farber Cancer Institute|
|Study Chair:||Ronald L. Burkes, MD, FRCPC||Mount Sinai Hospital, Toronto|
|Study Chair:||Claude Deschamps, MD||Mayo Clinic|