Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

Phase 2

Terminated

• Conditions: Lung Cancer

• Registration Number: NCT00021112
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.

Detailed Description

OBJECTIVES:

* Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin, etoposide, and radiotherapy followed by surgical resection.

* Determine the toxicity (morbidity and mortality) of this regimen in these patients.

* Determine the clinical response rate and pathological response rate in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy repeats every 3 weeks for 3 courses. Beginning on day 2 of the second course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks. Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity.

At 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo lobectomy or pneumonectomy.

Patients are followed at 30 days and 4 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 27-62 patients will be accrued for this study.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2001-07-11
• Primary Completion: 2002-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

Academisch Ziekenhuis Utrecht; 🇳🇱 Utrecht, Netherlands

Algemeen Ziekenhuis Middelheim; 🇧🇪 Antwerp, Belgium

University Hospital - Rotterdam Dijkzigt; 🇳🇱 Rotterdam, Netherlands

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Sint Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Thoraxklinik Rohrbach; 🇩🇪 Heidelberg, Germany

Gelre Ziekenhuizen - Lokatie Lukas; 🇳🇱 Apeldoorn, Netherlands

Rotterdam Cancer Institute; 🇳🇱 Rotterdam, Netherlands

National Institute of Tuberculosis and Lung Diseases; 🇵🇱 Warsaw, Poland

Medical University of Gdansk; 🇵🇱 Gdansk, Poland