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

September 22, 2023 updated by: Fernando Pereira, Hospital Universitario de Fuenlabrada

Phase IV Multicentric 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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

CytoReductive Surgery (CRS) + Hyperthermic IntraPEritoneal Chemotherapy (HIPEC), especially from the year 2000 onwards, has obtained unprecedented results in patients with low to moderate volume peritoneal metastases (PM) of colorectal cancer (CRC), so that it has gradually been accepted, even being considered the best treatment for these patients. However, the actual role of HIPEC as a necessary component of treatment is unknown, despite its proven experimental basis. The French PRODIGE 7 study, presented at ASCO in 2018 and published on January 2021, has raised doubts about the survival benefit of HIPEC. In this study, there was no difference in overall survival (OS) with or without HIPEC (with Oxaliplatin 30 minutes) after resection of PM-CRC. However, since its presentation, several methodological flaws have been identified: a short exposure time to Oxaliplatin, an overestimation of the effect of HIPEC on OS (18 months) considered for the sample calculation, or the choice of OS as the main endpoint (since HIPEC can reduce peritoneal relapses, while OS is also influenced by the systemic treatment received by all patients). Due to these shortcomings and some others, the results have not been assumed to be definitive. Therefore, the majority of units specialized in peritoneal surface malignancy, continue to consider HIPEC in these patients as a recommended option, usually changing Oxaliplatin for Mitomycin-C (MMC). With these premises we propose this multicenter Clinical Trial, correcting the retrospective defects of PRODIGE 7. To do this, the cytostatic used in HIPEC will be changed (MMC instead of oxaliplatin), the infusion time will be increased (from 30 to 90 minutes), rectal cancers are ruled out (only colon cancers will be included), cases with high peritoneal extension (PCI> 20) will be avoided, those cases in which a complete CRS (CCS 0) is not achieved will be excluded, and the main objective will be the Peritoneal Recurrence Free Survival (RFS) instead of the OS.

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Almería, Spain, 04009
      • Badajoz, Spain, 6080
        • Recruiting
        • Complejo Hospitalario Universitario de Badajoz
        • Contact:
      • Ciudad Real, Spain, 13005
      • Córdoba, Spain, 14004
      • Madrid, Spain, 28034
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Contact:
      • Madrid, Spain, 28040
      • Madrid, Spain, 28033
      • Murcia, Spain, 30003
        • Recruiting
        • Hospital General Universitario Reina Sofía
        • Contact:
      • Málaga, Spain, 29004
        • Not yet recruiting
        • Hospital Quironsalud Malaga
        • Contact:
      • Sevilla, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
        • Contact:
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politécnico La Fe
        • Contact:
      • Valencia, Spain, 46009
      • Valladolid, Spain, 47012
      • Zaragoza, Spain, 50009
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
        • Contact:
    • Asturias
      • Oviedo, Asturias, Spain, 33011
    • Barcelona
    • Castellón
      • Castelló de la Plana, Castellón, Spain, 12004
      • Castellón De La Plana, Castellón, Spain, 12006
        • Recruiting
        • Consorcio Hospitalario Provincial de Castellón
        • Contact:
    • Gipuzkoa
      • San Sebastián, Gipuzkoa, Spain, 20014
        • Not yet recruiting
        • Hospital Universitario Donostia
        • Contact:
    • Gran Canaria
      • Las Palmas De Gran Canaria, Gran Canaria, Spain, 35010
        • Recruiting
        • Hospital Universitario de Gran Canaria Doctor Negrin
        • Contact:
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28805
      • Alcorcón, Madrid, Spain, 28922
        • Not yet recruiting
        • Hospital Universitario Fundacion Alcorcon
        • Contact:
      • Fuenlabrada, Madrid, Spain, 28942
        • Recruiting
        • HOSPITAL UNIVERSITARIO DE FUENLABRADA (Coordinating Centre)
        • Contact:
        • Sub-Investigator:
          • Angel SERRANO, PhD
        • Sub-Investigator:
          • Israel MANZANEDO, PhD
        • Sub-Investigator:
          • Estibalitz PÉREZ-VIEJO, PhD
      • Valdemoro, Madrid, Spain, 28340
        • Recruiting
        • Hospital Universitario Infanta Elena
        • Contact:
    • Mallorca
      • Palma De Mallorca, Mallorca, Spain, 07210
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Not yet recruiting
        • Hospital Universitario Virgen de la Arrixaca
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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).
  2. 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).
  3. Synchronous or metachronous peritoneal metastasis of mild to moderate volume, with a PCI ≤ 20 (Appendix 2) (intraoperative confirmation).
  4. Macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation).
  5. Treatment with perioperative systemic chemotherapy (SCT), before and/or after surgical procedure.
  6. Age> 18 years.
  7. Acceptable anesthetic/surgical risk: ASA 1-3 (Appendix 3), ECOG 0-1 (Appendix 4). No severe alterations in hematological, renal, cardiac, pulmonary or hepatic function (operable patients).
  8. Information to the patient and signing of a study-specific informed consent.

Exclusion Criteria:

  1. Peritoneal carcinomatosis of any other origin, particularly rectal cancer or appendicular adenocarcinoma, or signet ring cell colon cancer on histology.
  2. No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases of perianastomotic (local) or lymph node (locoregional) recurrences will be excluded.
  3. High volume peritoneal disease with a PCI> 20 (intraoperative evaluation).
  4. Concurrent or previously treated extraperitoneal disease.
  5. Disease progression during preoperative chemotherapy, if received.
  6. Patients previously treated with HIPEC.
  7. History of other cancers (except cutaneous basal cell carcinoma or cervix carcinoma in situ) in the 5 years prior to entry into the study.
  8. Patients included in another first-line clinical trial for the studied disease.
  9. Pregnancy (or suspicion of it) or lactation period.
  10. Emergency surgical intervention for obstruction or perforation of a primary tumour with synchronous PM (although rescue and secondary CRS + HIPEC after emergency surgery of the primary tumour are acceptable if inclusion criteria are fulfilled).
  11. Persons deprived of liberty or under legal or administrative supervision.
  12. Inability to understand the nature of the intervention, the risks, benefits, expected evolution and the need to undergo periodic medical examinations, either for geographical, social or psychological reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes
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
Experimental: complete cytoreductive surgery without HIPEC
Procedure: complete cytoreductive surgery without HIPEC
in the arm without HIPEC, only complete cytoreductive surgery will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peritoneal Recurrence Free Survival
Time Frame: 3 years
From the date of surgery to the date of peritoneal recurrence or death, or to the end of follow-up
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global recurrence at any location (Disease Free Survival)
Time Frame: 3 years
From the date of surgery to the date of recurrence at any site or death
3 years
Locoregional and distant recurrence rate (isolated or coincident, with or without simultaneous peritoneal recurrence)
Time Frame: 3 years
From the date of surgery to the date of locoregional and/or distant recurrence
3 years
Postoperative complications (rate and severity grade)
Time Frame: days 1-90 after surgery
Using the CTCAE v5.0 adverse event classification system, including those related to HIPEC.
days 1-90 after surgery
Peritoneal and global recurrence rate according to stratified PCI
Time Frame: 3 years
Rate of peritoneal and global recurrence in 3 subgroups of PCI ((1-10, 11-15, 16-20)
3 years
Overall survival
Time Frame: 3 years
Months from from the day of treatment initiation (either neoadjuvant SCT or upfront CRS) to the date of death or to the end of follow-up.
3 years
Quality of Life with EORTC validated questionnaire Core 30 (QLQ-C30)
Time Frame: pre-surgery, at the end of postoperative SCT (an average 4-6 months), at 12 months and at 24 months
The QLQ-CR29 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. In fact, their numbering is consecutive (the last item of QLQ-C30 is number 30, being the first item of QLQ-CR29 number 31). Both have function and symptom scales/single-items. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.
pre-surgery, at the end of postoperative SCT (an average 4-6 months), at 12 months and at 24 months
Quality of Life with EORTC validated questionnaire Colorectal Cancer Module (QLQ-CR29).
Time Frame: pre-surgery, at the end of postoperative SCT (an average 4-6 months), at 12 months and at 24 months
The QLQ-CR29 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. In fact, their numbering is consecutive (the last item of QLQ-C30 is number 30, being the first item of QLQ-CR29 number 31). Both have function and symptom scales/single-items. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.
pre-surgery, at the end of postoperative SCT (an average 4-6 months), at 12 months and at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario de Fuenlabrada

Collaborators

Instituto de Investigación Hospital Universitario La Paz

Investigators

  • Principal Investigator: Fernando Pereira, PhD, Hospital Universitario de Fuenlabrada, Madrid, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 23, 2022

First Submitted That Met QC Criteria

February 20, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECOP-MMC
  • 2019-004679-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication, after deidentification (text, tables, figures and appendices) With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? for individual participant data meta-analysis.

IPD Sharing Time Frame

The data will be available beginning 9 months and ending 36 months following article publication

IPD Sharing Access Criteria

To obtain the data, a proposal must be sent to fernando.pereira@salud.madrid.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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