A Phase 2 interventional study of Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC in Peritoneal Carcinomatosis and Gastric Cancer, sponsored by Hospital General Universitario Gregorio Marañon. Suspended at 3 sites in Spain. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2016-11-21.
Sponsored by Hospital General Universitario Gregorio Marañon · Phase 2, Interventional, and Treatment
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.
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).
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 50 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Hospital General Universitario Gregorio Marañon is the lead sponsor of 59 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC
see Design
disease free survival
patients who reached optimum cytoreduction (CC0)after Phase II and eligible to complete adjuvant treatment(Phase III).
Time frame: 36 months
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
This study is suspended, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hospital General Universitario Gregorio Marañon