A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer
fluorouracil
+ leucovorin calcium
+ conventional surgery
Maladies du système digestif+5
+ Néoplasmes du système digestif
+ Maladies du système endocrinien
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 1997
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Assess the overall survival of patients with resectable ductal pancreatic adenocarcinoma undergoing extended versus standard pancreatoduodenectomy. OUTLINE: Patients are randomized to undergo standard pancreatoduodenectomy (PD) or PD with extended lymph node resection after an exploratory laparotomy. Patients receive adjuvant chemoradiation therapy 4-6 weeks after surgery, if no metastases are evident. Radiation therapy is given every week for 5 weeks. Fluorouracil/leucovorin calcium is administered by rapid IV push daily within 2 hours of radiation on days 1-4 of week 1 and days 29-31 of week 5. Patients are followed every 4 months for the first year, then every 6 months for the next 2 years. PROJECTED ACCRUAL: 50 patients will be accrued per group for a total of 100 patients.
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.100 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 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 or cytologically proven adenocarcinoma of the exocrine pancreas excluding periampullary cancer Resectable malignancy must be located in a region that can be encompassed by a radiation port of 20 x 20 cm No evidence of extranodal metastatic disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Not specified Renal: Bilateral renal function as demonstrated by excretory urogram (IVP) or abdominal CT scan with contrast OR Greater than 2/3 of one functioning kidney must be shielded during radiation therapy Other: Must have adequate oral nutrition (greater than 1200 calories daily) Greater than 5 years since prior malignancy except: Squamous cell skin cancer Basal cell skin cancer In situ cervical cancer Not pregnant or lactating Patients of reproductive potential must use effective birth control No cystic neoplasms of the pancreas No islet cell, periampullary or cholangiocarcinoma No Federal Medical Center inmates PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this disease Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy for this disease No prior radiation therapy to the abdomen Surgery: Celiotomy and standardized exploration for resectability required
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