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Clinical Trial at Neoadjuvant Peritoneal and Systemic Chemotherapy Plus HIPEC in Gastric Carcinomatosis
Conditions
Peritoneal Carcinomatosis - Gastric Cancer
Conditions: official terms
Carcinoma - Stomach Neoplasms
Conditions: Keywords
Peritoneal, Carcinomatosis, Gastric, Cancer, NIPS, HIPEC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC
Type: Other
Overall Status
Recruiting
Summary
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.
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
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).
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 64 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Men and women aged 18-65 years old
- Hystological 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 Hystological 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
- Men and women aged 18-65 years old
- Hystological 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 Hystological 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
Locations
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Centro Oncologico MD Anderson International España
Status: Recruiting
Contact: Gloria Ortega, MD - GOrtega@mdanderson.es
Madrid, Spain
Hospital General Universitario Gregorio Marañon
Status: Recruiting
Contact: Santiago Gonzalez, MD, PhD - sgonzalez@mdanderson.es
Madrid, Spain
Status: Recruiting
Contact: Luis A Gonzalez, MD, PhD - 0034915868836 - lgonzalezb.hgugm@salud.madrid.org
Start Date
January 2011
Completion Date
January 2017
Sponsors
Hospital General Universitario Gregorio Marañon
Source
Hospital General Universitario Gregorio Marañon
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page