Thérapie d'induction à base de Paclitaxel et de Carboplatine avec radiothérapie concomitante pour le cancer du poumon non à petites cellules localement avancé et non résécable
Cette étude vise à évaluer l'efficacité de la thérapie d'induction à base de Paclitaxel et de Carboplatine combinée à une radiothérapie concomitante pour le traitement du cancer du poumon non à petites cellules localement avancé et non résécable.
amifostine trihydrate
+ carboplatin
+ paclitaxel
Adénocarcinome+14
+ Néoplasmes bronchiques
+ Carcinome
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1997
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Determine the toxic effects and antitumor efficacy of paclitaxel plus carboplatin in patients with unresectable, intrathoracic non-small cell lung cancer (NSCLC). II. Integrate concurrent thoracic radiation therapy and weekly low dose paclitaxel into treatment of this patient population. III. Investigate a primary chemoradiotherapy treatment approach in a population of patients selected on the basis of performance status regardless of degree of weight loss. IV. Determine the effect of amifostine on the incidence of treatment nonhematologic toxic effects, specifically esophagitis, pneumonitis, and radiation dermatitis, in these patients. OUTLINE: This is an open label study. Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on days 1 and 21. Patients then undergo radiotherapy beginning on day 42 (or no later than day 63) daily 5 days a week for 7 weeks. Patients also receive amifostine IV over 15 minutes followed by paclitaxel IV over 3 hours weekly (day 1 each week) concurrently for the duration of radiotherapy. On 2 other days of the week, patients receive amifostine alone preceding thoracic radiotherapy. Patients are followed every 3 months for 1 year and then every 6 months until disease progression or death. PROJECTED ACCRUAL: Approximately 15-35 patients will be accrued for this study.
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.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 Adenocarcinoma Squamous cell carcinoma Large cell carcinoma Undifferentiated carcinoma Stages II-IIIB Medically inoperable stage II and IIIA Unresectable stage IIIA and IIIB Partial resection of stage IIIA or IIIB disease with histologically proven mediastinal lymph node involvement with microscopic or measurable disease Ineligible for RTOG 9410 or RTOG 9304 Men with elevated PSA no greater than 10 and no clinical evidence of prostate carcinoma are eligible No pleural effusion large enough to be visible by plain chest radiograph, unless proven to be benign Limited metastatic disease (no liver metastases) defined as: No more than 3 lung nodules outside the primary tumor suspected to be metastatic OR No more than 3 sites of suspected metastatic disease seen on bone scan or skeletal films OR 1-3 brain metastases, with plans for whole brain irradiation, with or without surgery or radiosurgery OR Single adrenal metastases not exceeding 3 cm in size PATIENT CHARACTERISTICS: Age: Adult Performance status: ECOG 0-1 OR Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 8 g/dL Hepatic: Transaminases less than 1.5 times normal Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 1.8 mg/dL Other: No concurrent severe medical problems Calorie intake of at least 1500 kcal/day No history of active malignancy within one year except: Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Superficial transitional cell carcinoma of the urothelium Cervical intraepithelial neoplasia Stage I cancer of the endometrium Stage I cancer of the upper aerodigestive tract PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic radiotherapy Surgery: See Disease Characteristics
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 1 site
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, United StatesOuvrir Kimmel Cancer Center of Thomas Jefferson University - Philadelphia dans Google Maps