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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: | NCT00003803 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy used high-energy x-rays to damage tumor cells. It is not yet know whether chemotherapy followed by radiation therapy is more effective than chemotherapy given with radiation therapy for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have unresectable stage I, stage II, or stage III non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III |
Estimated Enrollment: | 418 |
Study Start Date: | February 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1), TNM stage, and participating center. Patients are randomized to one of two treatment arms.
Quality of life is assessed before treatment and at weeks 9-11, 19, 27, and 35.
Patients are followed at 3 weeks, 6-7 weeks, and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 418 patients (209 per arm) will be accrued for this study within 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Stage I, II, III (T1-4, N0-3, M0)
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 | |
Hopital de Jolimont | |
Haine Saint Paul, Belgium, 7100 | |
France | |
CHR de Grenoble - La Tronche | |
Grenoble, France, 38043 | |
Germany | |
Mutterhaus der Borromaerinnen | |
Trier, Germany, D-54219 | |
Netherlands | |
Antoni van Leeuwenhoekhuis | |
Amsterdam, Netherlands, 1066 CX | |
Amphia Ziekenhuis - locatie Molengracht | |
Breda, Netherlands, 4818 CK | |
Amphia Ziekenhuis | |
Breda, Netherlands, 4810 EV | |
Academisch Medisch Centrum | |
Amsterdam, Netherlands, 1105 AZ | |
Catharina Ziekenhuis | |
Eindhoven, Netherlands, 5602 ZA | |
Dr. Bernard Verbeeten Instituut | |
Tilburg, Netherlands, 5042 SB | |
Gelre Ziekenhuizen - Lokatie Lukas | |
Apeldoorn, Netherlands, 7334 DZ | |
Medisch Centrum Haaglanden | |
's-Gravenhage (Den Haag, The Hague), Netherlands, 2501 CK | |
Radiotherapeutisch Instituut-(Riso) | |
Deventer, Netherlands, 7400 AC | |
Reinier de Graaf Group | |
Delft, Netherlands, NL 2600 GA | |
Sophia Ziekehuis | |
Zwolle, Netherlands, 8000 GK | |
Twee Steden Ziekenhuis Vestiging Tilburg | |
Tilburg, Netherlands, 5042 AD | |
United Kingdom, Scotland | |
Western General Hospital | |
Edinburgh, Scotland, United Kingdom, EH4 2XU |
Study Chair: | Jose Belderbos, MD | Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital |
Study ID Numbers: | CDR0000066947, EORTC-08972 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003803 |
Health Authority: | United States: Federal Government |
stage I non-small cell lung cancer stage II non-small cell lung cancer stage III non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Anti-Infective Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |