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

October 6, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Almería, Spain, 04009
        • Recruiting
        • Hospital Universitario Torrecárdenas
        • Contact:
        • Contact:
          • Juan TORRES MELERO
      • Badajoz, Spain, 6080
        • Recruiting
        • Complejo Hospitalario Universitario de Badajoz
        • Contact:
        • Contact:
          • iSABEL JAEN TORREJIMENO
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General Universitario de Ciudad Real
        • Contact:
        • Contact:
          • Susana SÁNCHEZ GARCÍA
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
        • Contact:
          • Alvaro ARJONA
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
        • Contact:
          • Julio GALINDO ÁLVAREZ
      • Madrid, Spain, 28046
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
        • Contact:
          • Luis GONZÁLEZ BAYÓN
      • Madrid, Spain, 28040
        • Recruiting
        • Fundación Jiménez Díaz
        • Contact:
        • Contact:
          • Pedro VILLAREJO
      • Madrid, Spain, 28033
        • Active, not recruiting
        • MD Anderson Cancer Center
      • Murcia, Spain, 30003
        • Recruiting
        • Hospital General Universitario Reina Sofía
        • Contact:
        • Contact:
          • Pedro Antonio PARRA BAÑOS
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Málaga
        • Contact:
        • Contact:
          • Joaquín CARRASCO
      • Málaga, Spain, 29004
        • Active, not recruiting
        • Hospital Quirónsalud Málaga
      • Sevilla, Spain, 41013
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
        • Contact:
        • Contact:
          • Maria Eugenia BARRIOS CARVAJAL
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politécnico La Fe
        • Contact:
        • Contact:
          • Javier VAQUÉ URBANEJA
      • Valencia, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncología
        • Contact:
        • Contact:
          • Alfonso GARCÍA FADRIQUE
      • Valladolid, Spain, 47012
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Clínico Universitario "Lozano Blesa"
        • Contact:
        • Contact:
          • Vicente Borrego
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
        • Contact:
        • Contact:
          • Alicia CALERO
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
        • Contact:
          • Estrella TURIENZO
    • Barcelona
      • Sant Joan Despí, Barcelona, Spain, 08970
        • Recruiting
        • Hospital Sant Joan Despí Moises Broggi
        • Contact:
        • Contact:
          • Lana BIJELIC
    • Castellón
      • Castelló de la Plana, Castellón, Spain, 12004
      • Castellón De La Plana, Castellón, Spain, 12006
        • Recruiting
        • Consorcio Hospitalario Provincial de Castellón
        • Contact:
        • Contact:
          • Enrique BOLDÓ RODA
    • Gipuzkoa
      • San Sebastián, Gipuzkoa, Spain, 20014
        • Active, not recruiting
        • Hospital Universitario Donostia
    • Gran Canaria
      • Las Palmas De Gran Canaria, Gran Canaria, Spain, 35010
        • Recruiting
        • Hospital Universitario de Gran Canaria Doctor Negrin
        • Contact:
        • Contact:
          • Manuel ARTILES
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28805
      • Alcorcón, Madrid, Spain, 28922
        • Recruiting
        • Hospital Universitario Fundacion Alcorcon
        • Contact:
        • Contact:
          • Manuel Emilio MARCELLO FERNANDEZ
      • Fuenlabrada, Madrid, Spain, 28942
        • Recruiting
        • HOSPITAL UNIVERSITARIO DE FUENLABRADA (Coordinating Centre)
        • Contact:
        • Contact:
          • Angel SERRANO, PhD
        • Contact:
          • Israel MANZANEDO, PhD
        • Contact:
          • Estibalitz PÉREZ-VIEJO, PhD
        • Contact:
          • Fernando Pereira
      • Valdemoro, Madrid, Spain, 28340
        • Recruiting
        • Hospital Universitario Infanta Elena
        • Contact:
        • Contact:
          • Cristina RIHUETE CARO
    • Mallorca
      • Palma De Mallorca, Mallorca, Spain, 07210
        • Recruiting
        • Hospital Universitario Son Espases
        • Contact:
        • Contact:
          • Rafael MORALES SORIANO
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Universitario Virgen de la Arrixaca
        • Contact:
        • Contact:
          • Pedro CASCALES CAMPOS

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitario de Fuenlabrada

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Investigación Hospital Universitario La Paz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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