A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach
cisplatin
+ fluorouracil
+ leucovorin calcium
Maladies du système digestif+5
+ Néoplasmes du système digestif
+ Maladies Gastro-intestinales
Étude thérapeutique
Résumé
Date de début de l'étude : 1 novembre 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach. Determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen. Determine the tolerability of this regimen in these patients. OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1-21, cisplatin IV over 1 hour on days 1-5, and leucovorin calcium IV over 15 minutes on days 1, 8, 15, and 22. A second course is administered beginning on day 29. Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest (day 57). Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1, 8, 15, 22, and 29. Approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic disease undergo surgical resection. Patients are followed every 3 months for 1 year, every 6 months for 5 years, then annually thereafter. PROJECTED ACCRUAL: A total of 21-49 patients will be accrued for this study within 2.5 years.
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.Jusqu'à 120 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 adenocarcinoma of the stomach Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0) No lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes) Potentially resectable May involve the gastroesophageal junction, but bulk of tumor must be in the stomach No distant metastases No pleural or pericardial effusion No peritoneal disease diagnosed by laparoscopy PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 16 weeks Hematopoietic: Absolute granulocyte count greater than 2,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No hypertension Neurologic: No cerebrovascular disease No diabetic neuropathy No mental status abnormalities Other: No uncontrolled diabetes No infection No other malignancies within past 5 years except resected squamous cell or basal cell skin cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to stomach Surgery: No prior surgery to stomach
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 55 sites
Providence Alaska Medical Center
Anchorage, United StatesOuvrir Providence Alaska Medical Center dans Google MapsFoundation for Cancer Research and Education
Phoenix, United StatesMount Diablo Medical Center
Concord, United StatesNorthridge Hospital Medical Center
Northridge, United States