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Sponsored by: |
European Organization for Research and Treatment of Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00062335 |
RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage II, or stage IIIA non-small cell lung cancer.
Condition | Intervention | Phase |
Lung Cancer |
Procedure: radiation therapy |
Phase I |
MedlinePlus related topics: | Cancer Lung Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study On The Feasibility Of High Dose Three Dimensional Conformal Radiotherapy In Patients With Inoperable And Locally Advanced Non Small Cell Lung Cancer |
Study Start Date: | April 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. Patients are assigned to 1 of 3 strata according to the total lung volume irradiated (less than 25% vs 25-37% vs over 37%).
Cohorts of 6-15 patients in each stratum receive escalating dose intensities of high-dose 3-D conformal radiotherapy (either by increasing the total dose or by shortening treatment time) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6, 2 of 15, or 3 of 30 patients experience dose-limiting toxicity.
Patients are followed at 1 month, at least every 2 months for 1 year, every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 54-135 patients (18-45 per stratum) will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Stage III disease eligible provided the following are true:
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 | |||||
Academisch Ziekenhuis der Vrije Universiteit Brussel | |||||
Brussels, Belgium, 1090 | |||||
Akademisch Ziekenhuis Gent | |||||
Ghent, Belgium, B-9000 | |||||
Institut Jules Bordet | |||||
Brussels, Belgium, 1000 | |||||
France | |||||
Centre Antoine Lacassagne | |||||
Nice, France, 06189 | |||||
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |||||
Montpellier, France, 34298 | |||||
Institut Curie - Section Medicale | |||||
Paris, France, 75248 | |||||
Switzerland | |||||
Centre Hospitalier Universitaire Vaudois | |||||
Lausanne, Switzerland, CH-1011 |
European Organization for Research and Treatment of Cancer |
Investigator: | Jacques Bernier, MD, PhD | Oncology Institute of Southern Switzerland |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000304729, EORTC-22994 |
First Received: | June 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00062335 |
Health Authority: | United States: Federal Government |
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