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Combination Chemotherapy Followed by Surgery in Treating Patients With Non-small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer
Registration Number
NCT00003231
Lead Sponsor
Swiss Group for Clinical Cancer Research
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 with surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with docetaxel and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer.

Detailed Description

OBJECTIVES: I. Assess the efficacy and toxic effects of docetaxel plus cisplatin in patients with stage IIIA non-small cell lung cancer. II. Assess the clinical and pathological response rate to this therapy in this patient population. III. Compare the benefit of surgery in terms of overall survival of responding and nonresponding patients.

OUTLINE: Patients receive infusions of docetaxel over 1 hour on day 1, followed by infusions of cisplatin over 1 hour on days 1-2. Treatment is repeated for three 21 day courses. Patients undergo tumor resection and mediastinal lymph node dissection. Patients are to receive postoperative radiotherapy within 4 weeks of resection if the tumor reaches the resection margins and/or the first mediastinal lymph node levels are involved. Patients will be followed until death.

PROJECTED ACCRUAL: Approximately 5-40 patients will be accrued within 3 years.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (9)

Kantonspital Aarau

🇨🇭

Aarau, Switzerland

University Hospital

🇨🇭

Basel, Switzerland

Inselspital, Bern

🇨🇭

Bern, Switzerland

Office of Walter Weber-Stadelman

🇨🇭

Basel, Switzerland

City Hospital Triemli

🇨🇭

Zurich, Switzerland

Burgerspital, Solothurn

🇨🇭

Solothurn, Switzerland

Hopital Cantonal Universitaire de Geneva

🇨🇭

Geneva, Switzerland

Klinik Hirslanden

🇨🇭

Zurich, Switzerland

Istituto Oncologico della Svizzera Italiana

🇨🇭

Lugano, Switzerland

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