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

NCT01342653 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-11-21

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC

see Design

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01342653 on ClinicalTrials.gov