A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY POST INDUCTION CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED INOPERABLE, NON-SMALL CELL LUNG CANCER
radiation therapy
Adénocarcinome+12
+ Néoplasmes bronchiques
+ Carcinome
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1995
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Assess the treatment related morbidity associated with escalating doses of 3-dimensional conformal radiotherapy (3D-CRT) in patients with locally advanced, inoperable, non-small cell lung cancer. II. Determine the maximum tolerated dose of 3D-CRT in these patients. III. Evaluate the morbidity associated with high dose 3D-CRT for carcinoma of the lung. OUTLINE: This is a dose escalation study. Patients are stratified by the percentage of total lung volume (TLV) receiving greater than 20 Gy of radiation (less than 25% vs 25% to less than 37% vs at least 37%). As of 7/1/1999, the third stratum closed to accrual. Patients receive 3-dimensional conformal radiotherapy (3D-CRT) 5 days a week for either 6-7 weeks, 7-8 weeks, or 9-10 weeks (depending on the cohort). Within each TLV stratum, cohorts of 15-36 patients receive escalating doses of 3D-CRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which less than 15% of patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 15-36 patients per cohort will be accrued for this study within 1 year. As of 7/1/1999, the third stratum closed to accrual.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.36 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: Histologically proven non-small cell lung cancer of the following histologic types: Squamous cell carcinoma Adenocarcinoma Undifferentiated large cell carcinoma Not otherwise specified (i.e., diagnosis by cytology alone) Unresectable stage I, II, or III disease Measurable lesion Primary and nodal lesions encompassable within radiotherapy fields No positive supraclavicular lymph nodes (stage N3) No massive atelectasis No complete remission if treated with chemotherapy Prior cisplatin, vinblastine, etoposide, paclitaxel, carboplatin, or vinorelbine allowed All chemotherapy delivered within 4 months of entry No pleural effusion with positive cytology Other pleural effusions eligible with following requirements: Present prior to mediastinoscopy or exploratory thoracotomy Transudate cytologically negative on 2 separate thoracenteses OR Present after mediastinoscopy or exploratory thoracotomy Either transudate or exudate with negative cytology on thoracentesis OR Present only on CT and not on chest x-ray Too small to tap under CT or ultrasound guidance Ineligible for treatment on RTOG phase III studies PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within the past 5 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic response modifier therapy Chemotherapy: See Disease Characteristics At least 6 months since prior bleomycin, mitomycin, doxorubicin, or cyclophosphamide No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic irradiation Surgery: Ineligible for definitive surgery
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 242 sites
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesOuvrir University of Alabama at Birmingham Comprehensive Cancer Center dans Google MapsHuntsville Hospital System
Huntsville, United StatesComprehensive Cancer Institute of Huntsville
Huntsville, United StatesMBCCOP - Gulf Coast
Mobile, United States