- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00062335
High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
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
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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Brussels, Belgique, 1000
- Institut Jules Bordet
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Brussels, Belgique, 1090
- Academisch Ziekenhuis der Vrije Universiteit Brussel
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Ghent, Belgique, B-9000
- Akademisch Ziekenhuis Gent
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Montpellier, France, 34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Nice, France, 06189
- Centre Antoine Lacassagne
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Paris, France, 75248
- Institut Curie - Section Medicale
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Lausanne, Suisse, CH-1011
- Centre Hospitalier Universitaire Vaudois
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
- Medically inoperable stage I or II disease
Stage III disease eligible provided the following are true:
- No supraclavicular node involvement
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy
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Mesures de résultats secondaires
Mesure des résultats |
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Late toxicity measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter
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Disease progression measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter
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Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Jacques Bernier, MD, PhD, Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EORTC-22994
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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