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Outcome Measures

Primary Outcomes (1)

Peritoneal Recurrence Free Survival
From the date of surgery to the date of peritoneal recurrence or death, or to the end of follow-up
3 years

Secondary Outcomes (7)

Global recurrence at any location (Disease Free Survival)
3 years
Locoregional and distant recurrence rate (isolated or coincident, with or without simultaneous peritoneal recurrence)
3 years
Postoperative complications (rate and severity grade)
days 1-90 after surgery
Peritoneal and global recurrence rate according to stratified PCI
3 years
Overall survival
3 years
+2 more secondary outcomes

Interventions

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutesDrug

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

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

complete cytoreductive surgery without HIPECProcedure

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically confirmed colon adenocarcinoma, except signet ring cell carcinomas (those with \> 50% of the tumor composed of these cells, which comprise only 1% of all colon adenocarcinomas).
Absence of previously treated or current extraperitoneal metastases, including distant lymphadenopathy (retroperitoneal, mediastinal, etc), liver metastases, or lung metastases (ruled out by PET-scan in case of doubt).

Related Publications (1)

Pereira F, Serrano A, Manzanedo I, Perez-Viejo E, Gonzalez-Moreno S, Gonzalez-Bayon L, Arjona-Sanchez A, Torres J, Ramos I, Barrios ME, Cascales P, Morales R, Boldo E, Garcia-Fadrique A, Arteaga X, Gutierrez-Calvo A, Sanchez-Garcia S, Asensio E, Ramirez CP, Artiles M, Vaque J, Parra PA, Villarejo P, Munoz-Casares C, Turienzo E, Calero A, Torrejimeno IJ, Prieto I, Galindo J, Borrego V, Marcello ME, Rihuete C, Carrasco J, Gomez-Quiles L. GECOP-MMC: phase IV randomized clinical trial to evaluate the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) with mytomicin-C after complete surgical cytoreduction in patients with colon cancer peritoneal metastases. BMC Cancer. 2022 May 12;22(1):536. doi: 10.1186/s12885-022-09572-7.

PMID: 35549912RESULT

MeSH Terms

Conditions

Peritoneal NeoplasmsColonic Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic Diseases

Study Design

Study Type

interventional

Phase

phase 4

Allocation

RANDOMIZED

Masking

NONE

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Recruitment will be carried out at the outpatient clinic, once the indication of CRS ± HIPEC (CC-PM of apparently limited volume without metastasis at other sites) has been established after presenting the case in the Multidisciplinary Tumour Board. Eligible patients need to meet the presurgical inclusion criteria (even though some criteria have to be confirmed during surgery for randomization), and sign the informed consent. Randomization occurs intraoperatively, once the extension of peritoneal disease is found to be truly limited (PCI ≤ 20) after complete surgical exploration, and only after radical surgery (CCS 0) has been possible. At this time, patients are randomized to receive HIPEC with MMC for 90 minutes (Arm 1), or no HIPEC and therefore surgery is finished (Arm 2).

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Principal Investigator, Head of Surgery Dpt, Clinical Professor

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

complete cytoreductive surgery without HIPEC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

complete cytoreductive surgery without HIPEC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations