Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial
Cisplatin and Docetaxel
Maladies du système digestif+6
+ Néoplasmes du système digestif
+ Maladies de l'œsophage
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mars 2003
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the effectiveness of neoadjuvant docetaxel and cisplatin and chemoradiotherapy followed by surgery, in terms of pathological response rate, in patients with locally advanced, resectable esophageal cancer. * Determine the feasibility of this regimen, in terms of successful completion of therapy and survival at 30 days postoperatively, in these patients. Secondary * Determine the parameters of disease control in these patients and toxicity of this regimen and compare these parameters with published results. * Correlate early improvement of dysphasia after 1-2 courses of chemotherapy with predictive value with regard to tumor response and long-term disease control in patients treated with this regimen. * Determine the quality of life of patients treated with this regimen. * Determine the clinical benefit of this regimen in these patients. OUTLINE: This is a multicenter study. * Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 and 22. * Chemoradiotherapy: Beginning 21 days after the last dose of neoadjuvant chemotherapy, patients receive docetaxel IV over 30 minutes and cisplatin IV over 1 hour once a week and undergo radiotherapy 5 days a week for 5 weeks. * Surgery: Patients undergo surgery 3-8 weeks after the final administration of radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, day 22 of chemotherapy, day 1 of chemoradiotherapy, before surgery, and then every 3 months for 1 year. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 22-66 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.66 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.De 18 à 70 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 confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I) * Locally advanced disease that is technically operable with curative intent (R0) * T3, N0 OR T1-3, N+ OR T4, NX * No T1-2, N0 * No inoperable T4 (unequivocal organ involvement) * No distant metastasis, including M1a lymph node status * Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology * No carcinoma of the cervical esophagus * Obstructive tumors allowed PATIENT CHARACTERISTICS: Age * 18 to 70 Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * AST no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN * Bilirubin no greater than 1.5 times ULN Renal * Creatinine clearance greater than 60 mL/min Cardiovascular * No New York Heart Association class III or IV congestive heart failure * No unstable angina pectoris * No myocardial infarction within the past 3 months * No significant arrhythmias * No other severe or uncontrolled cardiovascular disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after study treatment * No definite contraindications to corticosteroids as premedication * No geographic situation that would preclude proper staging and follow-up * No active uncontrolled infection * No preexisting peripheral neuropathy greater than grade 1 * No uncontrolled diabetes mellitus * No active autoimmune disease * No other serious medical condition that would preclude study participation * No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix * No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures that would preclude comprehension and ability to provide informed consent and complete quality of life questionnaires PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the chest Surgery * Not specified Other * More than 30 days since prior treatment on another clinical trial * No other concurrent experimental drugs
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
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 9 sites
Universitaetsspital-Basel
Basel, SwitzerlandInselspital Bern
Bern, SwitzerlandSpitaeler Chur AG
Chur, Switzerland