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Sponsored by: |
Swiss Group for Clinical Cancer Research |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00030771 |
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 before surgery may shrink the tumor so that it can be removed. It is not yet known if chemotherapy plus radiation therapy is more effective than chemotherapy alone before surgery in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy followed by surgery in treating patients who have non-small cell lung cancer that has spread to lymph nodes in the chest.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: cisplatin Drug: docetaxel Procedure: conventional surgery Procedure: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Preoperative Chemoradiotherapy Vs. Chemotherapy Alone In Non-Small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2): A Randomized Prospective Phase III Trial |
Estimated Enrollment: | 120 |
Study Start Date: | April 2001 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to mediastinal bulk (5 cm or more vs less than 5 cm), weight loss in the past 6 months (5% or more vs less than 5%), and participating center. Patients are randomized to 1 of 2 treatment arms.
All patients undergo blood collection periodically for translational research studies.
Patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study within 4 years.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Stage IIIA (T1-3, N2, M0)
N2 disease confirmed by 1 of the following:
Bronchoscopy with fine-needle aspiration or esophagoscopy
PET scan
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Switzerland | |
Hopital Cantonal Universitaire de Geneve | Recruiting |
Geneva, Switzerland, CH-1211 | |
Contact: Arnaud Roth, MD 41-22-372-7744 arnaud.roth@sim.hcuge.ch | |
Inselspital Bern | Recruiting |
Bern, Switzerland, CH-3010 | |
Contact: Adrian Ochsenbein, MD 41-31-632-8169 adrian.ochsenbein@insel.ch | |
Kantonspital Aarau | Recruiting |
Aarau, Switzerland, CH-5001 | |
Contact: Walter Mingrone, MD 41-62-838-6050 | |
Kantonsspital Baden | Recruiting |
Baden, Switzerland, CH-5404 | |
Contact: Clemens B. Caspar, MD 41-56-486-2511 | |
Kantonsspital Bruderholz | Recruiting |
Bruderholz, Switzerland, CH-4101 | |
Contact: Lorenz M. Jost, MD 41-61-436-3636 lorenz.jost@ksbh.ch | |
Universitaetsspital-Basel | Recruiting |
Basel, Switzerland, CH-4031 | |
Contact: Cornelia Droege, MD 41-61-265-5075 cdroege@uhbs.ch | |
Kantonsspital Winterthur | Recruiting |
Winterthur, Switzerland, CH-8401 | |
Contact: Miklos Pless, MD 41-52-266-2552 miklos.pless@ksw.ch | |
Regionalspital | Recruiting |
Thun, Switzerland, 3600 | |
Contact: Daniel Rauch 41-33-226-2626 | |
Saint Claraspital AG | Recruiting |
Basel, Switzerland, CH-4016 | |
Contact: Christian U. Ludwig, MD 41-61-691-8585 christian.ludwig@claraspital.ch | |
Recruiting | |
Baden, Switzerland, CH-5404 | |
Contact: Antoinette Streit, MD 41-56-221-1474 | |
Kantonsspital Liestal | Recruiting |
Liestal, Switzerland, CH-4410 | |
Contact: Andreas Lohri, MD 41-61-925-2710 andreas.lohri@ksli.ch |
Study Chair: | Miklos Pless, MD | Kantonsspital Winterthur |
Study ID Numbers: | CDR0000069196, SWS-SAKK-16/00, EU-20138 |
Study First Received: | February 14, 2002 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00030771 |
Health Authority: | Unspecified |
squamous cell lung cancer large cell lung cancer stage IIIA non-small cell lung cancer adenosquamous cell lung cancer |
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |