Clinical Trial at Neoadjuvant Peritoneal and Systemic Chemotherapy Plus HIPEC in Gastric Carcinomatosis (HIPEC)
Implementation of a curative strategy of treatment in peritoneal carcinomatosis of gastric cancer. The goal is to get 1C level of evidence (patient died with "standard" treatment, with this treatment some of them survive) in terms of disease free survival and overall survival.
Methodology: prospective, phase II, multicentric in Spain. Recruitment of 50 patients(to have 31 on treatment) in three years. This strategy is based on neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy(NIPS),to treat peritoneal disease by bi-directional approach; next step is cytoreductive surgery and HIPEC. Once patients are discharged, they will follow a systemic adjuvant chemotherapy protocol.
|Peritoneal Carcinomatosis Gastric Cancer||Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Multicentric Exploratory Single Cohort Clinical Trial to Assess Efficacy and Safety on a New Treatment Scheme by Systemic and Peritoneal Chemotherapy Plus Cytoreduction and HIPEC Plus Adjuvant Treatment in Patients With Peritoneal Carcinomatosis From Gastric Cancer|
- disease free survival [ Time Frame: 36 months ]patients who reached optimum cytoreduction (CC0)after Phase II and eligible to complete adjuvant treatment(Phase III).
- progression free survival [ Time Frame: 36 months ]
- overall survival in patients with CC0 [ Time Frame: 36 month ]
- overall survival in patients who did not reach optimum cytoreduction [ Time Frame: 36 months ]
- morbidity and mortality [ Time Frame: first 30 days after surgery procedure ]
- Quality of life after phase I and Phase II [ Time Frame: 36 months ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
|Experimental: NIPS plus HIPEC plus adjuvant chemotherapy||
Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC
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 treatment):
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 cytoreduction.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342653
|Hospital Universitario de Fuenlabrada|
|Fuenlabrada, Madrid, Spain, 28942|
|Hospital General Universitario Gregorio Marañon|
|Madrid, Spain, 28007|
|Centro Oncologico MD Anderson International España|
|Madrid, Spain, 28033|