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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021112 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: cisplatin Drug: etoposide Procedure: conventional surgery Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy |
Study Start Date: | April 2001 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary stage IIIB non-small cell lung cancer (NSCLC)
At least 1 unidimensionally measurable target lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Belgium | |
Algemeen Ziekenhuis Middelheim | |
Antwerp, Belgium, 2020 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
Germany | |
Thoraxklinik Rohrbach | |
Heidelberg, Germany, D-69126 | |
Netherlands | |
Gelre Ziekenhuizen - Lokatie Lukas | |
Apeldoorn, Netherlands, 7334 DZ | |
Academisch Ziekenhuis Utrecht | |
Utrecht, Netherlands, 3584 CX | |
Sint Antonius Ziekenhuis | |
Nieuwegein, Netherlands, 3435 CM | |
University Hospital - Rotterdam Dijkzigt | |
Rotterdam, Netherlands, 3000 CA | |
Rotterdam Cancer Institute | |
Rotterdam, Netherlands, 3000 CA | |
Poland | |
Medical University of Gdansk | |
Gdansk, Poland, 80-211 | |
National Institute of Tuberculosis and Lung Diseases | |
Warsaw, Poland |
Study Chair: | Rob Van Klaveren, MD, PhD | University Medical Center Rotterdam at Erasmus Medical Center |
Study ID Numbers: | CDR0000068748, EORTC-08981 |
Study First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00021112 |
Health Authority: | United States: Federal Government |
stage IIIB non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Etoposide phosphate Etoposide Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |