Clinical Trial at Neoadjuvant Peritoneal and Systemic Chemotherapy Plus HIPEC in Gastric Carcinomatosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Peritoneal Carcinomatosis, Gastric Cancer

Intervention / Treatment
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* Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 18-65 years old Histological Evidence of peritoneal carcinomatosis from gastric cancer No distance metastasis ECOG 0-1-2 No contraindication for complex surgery no other malign disease except skin cancer (different from melanoma or cervix cancer CIN III) willing to consent and sign ICF. Exclusion Criteria: No Histological Evidence of peritoneal carcinomatosis from gastric cancer Previous Gastrectomy due to gastric cancer. Patients with gastric cancer and previous systemic chemotherapy Peritoneal recurrence due to gastric cancer. Distance metastasis SP >2 at recruitment or SP>1 at surgery previous radiotherapy treatment pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIPS plus HIPEC plus adjuvant chemotherapy<br> | Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC<br>* see Design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | patients who reached optimum cytoreduction (CC0)after Phase II and eligible to complete adjuvant treatment(Phase III). | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 36 months | 
| overall survival in patients with CC0 |  | 36 month | 
| overall survival in patients who did not reach optimum cytoreduction |  | 36 months | 
| morbidity and mortality |  | first 30 days after surgery procedure | 
| Quality of life after phase I and Phase II |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal, Carcinomatosis, Gastric, Cancer, NIPS, HIPEC