SWOG-9416: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: cisplatin; Drug: etoposide; Procedure: conventional surgery; Radiation: low-LET cobalt-60 gamma ray therapy

• Registration Number: NCT00002642
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1995-04
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-01
• Study First Submitted QC: 2004-06-29
• Study First Posted: 2004-06-30
• Study Completion: 2004-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-05
• Last Update Posted: 2012-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chemoradiotherapy followed by surgery	conventional surgery	chemoradiotherapy followed by surgery and post-surgery boost chemotherapy
chemoradiotherapy followed by surgery	low-LET cobalt-60 gamma ray therapy	chemoradiotherapy followed by surgery and post-surgery boost chemotherapy
chemoradiotherapy followed by surgery	cisplatin	chemoradiotherapy followed by surgery and post-surgery boost chemotherapy
chemoradiotherapy followed by surgery	etoposide	chemoradiotherapy followed by surgery and post-surgery boost chemotherapy

Primary Outcome Measures

Name	Time	Method
Feasibility	9-12 weeks after study entry	resectibility rate

Secondary Outcome Measures

Name	Time	Method
toxicity	16-20 weeks	Toxicity assessments per Southwest Oncology Group toxicity criteria
response rate	16-20 weeks after registration	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.

Trial Locations

Locations (1)

Vanderbilt Cancer Center; 🇺🇸 Nashville, Tennessee, United States