Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.
cisplatin
+ fluorouracil
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: Confirm the value of chronomodulated infusion with respect to survival in patients with locally advanced or metastatic pancreatic cancer. Test the value of adding cisplatin to fluorouracil in extending survival in these patients. OUTLINE: This is a multicenter, randomized study. The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment groups involving the use or absence of chronomodulation and cisplatin (CDDP). Treatment in each of the 4 groups is repeated for 3 courses where each course is a 5-day course of treatment. Patients in the first group receive a chronomodulated schedule based on delivery of fluorouracil (FU). Patients in the second group receive a chronomodulated schedule of FU and CDDP. Patients in the third and fourth experimental groups receive flat schedules of FU alone or FU and CDDP, respectively. Dosages of FU are increased across the three courses whereas dosages of CDDP remain constant. Treatment is continued until disease progression, severe toxicity, or complete remission for more than 4 months occurs. PROJECTED ACCRUAL: 200 patients will be accrued.
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.200 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: Histologic or cytologic proof of adenocarcinoma of the exocrine pancreas or of a metastasis associated with a radiologically identified pancreatic tumor Locally advanced and/or metastatic pancreatic cancer No measurable or evaluable target lesion is required No brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 40%-100% Hematopoietic: WBC at least 3,000/mm^3 Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 3 times normal Renal: Creatinine no greater than 1.24 mg/dL OR Creatinine clearance at least 80 mL/min Cardiovascular: No overt cardiac disease Other: No peripheral neuropathy No uncontrolled infectious or chronic disease No second primary except in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunologic therapy Chemotherapy: No prior chemotherapy allowed Endocrine therapy: No concurrent hormonal therapy At least 2 weeks since corticoid treatment Radiotherapy: No prior radiotherapy allowed except as an analgesic treatment on metastasis Surgery: Not specified
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 19 sites
Les Cliniques Saint-Joseph ASBL
Liège, BelgiumCentre Hospitalier de la Cote Basque
Bayonne, FranceCentre Jean Perrin
Clermont-Ferrand, France