Phase II Multicentric Exploratory Single Cohort Clinical Trial to Assess Efficacy and Safety on a New Treatment Scheme by Systemic and Peritoneal Chemotherapy Plus Citoreduction and HIPEC Plus Adjuvant Treatment in Patients With Peritoneal Carcinomatosis From Gastric Cancer
Patients with peritoneal carcinomatosis with gastric cancer who meet all inclusion
criteria(and none of exclusion) will follow the next treatment scheme(40 week period of
Phase I (after one week of peritoneal catheter implant; total treatment 5-8 weeks):
intraperitoneal infusion of Docetaxel(30 mg/m2) and Cisplatin (30mg/m2) in 1000 cc of
saline. Intravenous administration 5-FU (200 mg/m2/Day, 7 days a week for 2 weeks)
simultaneously with 2 cycles of Intraperitoneal administration.
These patients receive between four and six cycles of NIPS. Until phase II 4-6 weeks.
Phase II:cytoreduction (CR) plus HIPEC (total treatment 4 weeks). Maximal efforts to optimum
HIPEC: intraperitoneal administration: Mytomicin C (15mg/m2)plus Adriamycin (15mg/m2) at
42-43ºC for 60 minutes.
Intravenous simultaneously administration 5-FU (400mg/m2) plus Leucovorin (20mg/m2) for 10
minutes at the beginning of peritoneal perfusion.
Phase III: adjuvant chemotherapy 8-12 weeks after surgery. Those cases reaching optimum
cytoreduction (CC0) will be treated with systemic chemotherapy: First day: Docetaxel (75
mg/m2) Cisplatin (75mg/m2). Days 1-5: 5-FU (750mg/m2/d).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
disease free survival
patients who reached optimum cytoreduction (CC0)after Phase II and elegible to complete adjuvant treatment(Phase III).
Spain: Agencia Española de Medicamentos y Productos Sanitarios