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Clinical Trial on HIPEC with Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)

NCT05250648 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2024-10-09

No results posted yet for this study

Summary

The aim of this study is to assess whether there are differences in PERITONEAL RECURRENCE in patients with Colon Cancer Peritoneal Metastases treated with complete surgical resection and systemic chemotherapy, with (Group 1) or without (Group 2) HIPEC with Mitomycin-C.

Conditions

Interventions

DRUG

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

In the arm with HIPEC, this will be performed with Mytomicin C, at a dose of 35 mg/m2 in peritoneal dialysis solution (2 liter/m2) for 90 minutes, with dose fractionation: 50% min 0, 25% min 30, 25% min 60

PROCEDURE

complete cytoreductive surgery without HIPEC

in the arm without HIPEC, only complete cytoreductive surgery will be performed

Sponsors & Collaborators

  • Instituto de Investigación Hospital Universitario La Paz

    collaborator OTHER

  • Hospital Universitario de Fuenlabrada

    lead OTHER

Principal Investigators

  • Fernando Pereira, PhD · Hospital Universitario de Fuenlabrada, Madrid, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2029-10-31
Completion
2029-10-31

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 NCT05250648 on ClinicalTrials.gov