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

This study is currently recruiting participants.
Verified April 2011 by Hospital General Universitario Gregorio Marañon
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:
NCT01342653
First received: April 26, 2011
Last updated: November 12, 2012
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Peritoneal Carcinomatosis
Gastric Cancer
 Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 Citoreduction and HIPEC Plus Adjuvant Treatment in Patients With Peritoneal Carcinomatosis From Gastric Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital General Universitario Gregorio Marañon:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    patients who reached optimum cytoreduction (CC0)after Phase II and elegible to complete adjuvant treatment(Phase III).


Secondary Outcome Measures:
  • progression free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • overall survival in patients with CC0 [ Time Frame: 36 month ] [ Designated as safety issue: No ]
  • overall survival in patients who did not reach optimum cytoreduction [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • morbidity and mortality [ Time Frame: first 30 days after surgery procedure ] [ Designated as safety issue: Yes ]
  • Quality of life after phase I and Phase II [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
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)
Arms Assigned Interventions
Experimental: NIPS plus HIPEC plus adjuvant chemotherapy Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC
see Design

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).

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342653

Locations
Spain
Hospital Universitario de Fuenlabrada Recruiting
Fuenlabrada, Madrid, Spain, 28942
Contact: Gloria Ortega, MD         GOrtega@mdanderson.es    
Principal Investigator: Gloria Ortega, MD            
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Luis A Gonzalez, MD, PhD     0034915868836     lgonzalezb.hgugm@salud.madrid.org    
Contact: Wenceslao Vasquez, MD, PhD     0034915868836     tumi100@yahoo.com    
Principal Investigator: Luis A Gonzalez, MD, PhD            
Centro Oncologico MD Anderson International España Recruiting
Madrid, Spain, 28033
Contact: Santiago Gonzalez, MD, PhD         sgonzalez@mdanderson.es    
Principal Investigator: Santiago Gonzalez, MD, PhD            
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Instituto de Salud Carlos III
  More Information

No publications provided

Responsible Party: Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT01342653     History of Changes
Other Study ID Numbers: 2009-011162-29
Study First Received: April 26, 2011
Last Updated: November 12, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital General Universitario Gregorio Marañon:
Peritoneal
Carcinomatosis
Gastric
 Cancer
NIPS
HIPEC

Additional relevant MeSH terms:
Stomach Neoplasms
Carcinoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 19, 2013