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

ConditionsPeritoneal CarcinomatosisColon Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario de Fuenlabrada

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Synchronous or metachronous peritoneal metastasis of mild to moderate volume, with a PCI ≤ 20 (Appendix 2) (intraoperative confirmation).

Macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation).

Disqualifiers

Peritoneal carcinomatosis of any other origin, particularly rectal cancer or appendicular adenocarcinoma, or signet ring cell colon cancer on histology.

No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases of perianastomotic (local) or lymph node (locoregional) recurrences will be excluded.

High volume peritoneal disease with a PCI> 20 (intraoperative evaluation).

Concurrent or previously treated extraperitoneal disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

    Drug

    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 without HIPEC

    Procedure/Surgery

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

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutesActive comparator 1 intervention
Group B: complete cytoreductive surgery without HIPECExperimental treatment 1 intervention

Trial outcomes

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

Time frame
3 years

Secondary outcomes

1

Global recurrence at any location (Disease Free Survival)

From the date of surgery to the date of recurrence at any site or death

Time frame
3 years
2

Locoregional and distant recurrence rate (isolated or coincident, with or without simultaneous peritoneal recurrence)

From the date of surgery to the date of locoregional and/or distant recurrence

Time frame
3 years
3

Postoperative complications (rate and severity grade)

Using the CTCAE v5.0 adverse event classification system, including those related to HIPEC.

Time frame
days 1-90 after surgery
4

Peritoneal and global recurrence rate according to stratified PCI

Rate of peritoneal and global recurrence in 3 subgroups of PCI ((1-10, 11-15, 16-20)

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitario de Fuenlabrada

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborator

Source ClinicalTrials.gov
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