High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00062335
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Determine the optimal dose of high-dose 3-dimensional conformal radiotherapy in patients with inoperable stage I, II, or IIIA non-small cell lung cancer who are treated according to the total lung volume irradiated.
* Determine the feasibility of this regimen, in terms of local control rates and incidence of distant metastases, in these patients.
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%).
* Stratum I: Patients undergo high-dose 3-dimensional (3-D) conformal radiotherapy 5 days a week for 6 weeks.
* Stratum II: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-7 weeks.
* Stratum III: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-6.5 weeks.
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy
- Secondary Outcome Measures
Name Time Method Late toxicity measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter Disease progression measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter
Trial Locations
- Locations (7)
Centre Antoine Lacassagne
🇫🇷Nice, France
Institut Jules Bordet
🇧🇪Brussels, Belgium
Akademisch Ziekenhuis Gent
🇧🇪Ghent, Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels, Belgium
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Institut Curie - Section Medicale
🇫🇷Paris, France