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Trial Title:
Clinical Trial at Neoadjuvant Peritoneal and Systemic Chemotherapy Plus HIPEC in Gastric Carcinomatosis
NCT ID:
NCT01342653
Condition:
Peritoneal Carcinomatosis
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Carcinoma
Peritoneal Neoplasms
Conditions: Keywords:
Peritoneal
Carcinomatosis
Gastric
Cancer
NIPS
HIPEC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Suspended
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC
Description:
see Design
Arm group label:
NIPS plus HIPEC plus adjuvant chemotherapy
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.
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
64 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario de Fuenlabrada
Address:
City:
Fuenlabrada
Zip:
28942
Country:
Spain
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Facility:
Name:
Centro Oncologico MD Anderson International España
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Start date:
January 2011
Completion date:
January 2017
Lead sponsor:
Agency:
Hospital General Universitario Gregorio Marañon
Agency class:
Other
Collaborator:
Agency:
Instituto de Salud Carlos III
Agency class:
Other
Source:
Hospital General Universitario Gregorio Marañon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01342653
