High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
NCT ID: NCT00062335
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
14 participants
INTERVENTIONAL
2003-04-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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radiation therapy
Eligibility Criteria
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Inclusion Criteria
* No peripherally located lower lobe tumor AND contralateral upper mediastinal node involvement
* No distant metastasis
* No malignant pleural or pericardial effusion
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No prior myocardial infarction
* No prior complete bundle branch block
* No other prior cardiovascular disease resulting in New York Heart Association class III or IV heart disease
* No clinically significant cardiac arrhythmias
* No congestive heart failure
Pulmonary
* FEV\_1 at least 1.2 L OR
* DLCO at least 60%
Other
* No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix
* No intractable or uncontrolled infection
* No psychological, familial, social, or geographical condition that would preclude study compliance and follow-up
* Able to tolerate a course of radiotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 3 weeks since prior chemotherapy
* No prior anthracyclines
* No concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to the chest area
Surgery
* No prior therapeutic surgery to the chest area
Other
* No other prior therapy to the chest area
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Jacques Bernier, MD, PhD
Role: STUDY_CHAIR
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Locations
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Institut Jules Bordet
Brussels, , Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, , Belgium
Akademisch Ziekenhuis Gent
Ghent, , Belgium
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Institut Curie - Section Medicale
Paris, , France
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Countries
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Other Identifiers
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EORTC-22994
Identifier Type: -
Identifier Source: secondary_id
EORTC-22994
Identifier Type: -
Identifier Source: org_study_id