Peritoneal CarcinomatosisPhase 4GECOP-MMCNCT05250648
Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)
A Phase 4 study testing complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes and complete cytoreductive surgery without HIPEC in people with Peritoneal Carcinomatosis and Colon Cancer, run by Hospital Universitario de Fuenlabrada at 31 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis, Colon Cancer
- What is being tested?
- complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes and complete cytoreductive surgery without HIPEC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 31 sitesSpain
- Study dates
- 2 Mar 2022to Oct 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Treatment with perioperative systemic chemotherapy (SCT), before and/or after surgical procedure.
- Age> 18 years.
- 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).
- Information to the patient and signing of a study-specific informed consent.
Who cannot join
- 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.
- Disease progression during preoperative chemotherapy, if received.
- Patients previously treated with HIPEC.
Show all 12Show fewer
- History of other cancers (except cutaneous basal cell carcinoma or cervix carcinoma in situ) in the 5 years prior to entry into the study.
- Patients included in another first-line clinical trial for the studied disease.
- Pregnancy (or suspicion of it) or lactation period.
- 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).
- Persons deprived of liberty or under legal or administrative supervision.
- 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.
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
Spain31 sites, 28 recruiting
- Recruiting
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, 28805
Alberto GUTIERREZ CALVO, alberto.gutierrez@salud.madrid.org
Alberto GUTIERREZ CALVO
- Recruiting
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Manuel Emilio MARCELLO FERNANDEZ, mmarcello@fhalcorcon.es
Manuel Emilio MARCELLO FERNANDEZ
- Recruiting
Hospital Universitario Torrecárdenas
Almería, Almería, 04009
Juan TORRES MELERO, juantorresmelero@gmail.com
Juan TORRES MELERO
- Recruiting
Complejo Hospitalario Universitario de Badajoz
Badajoz, Badajoz, 6080
Isabel JAEN TORREJIMENO, isabel.jaen@salud-juntaex.es
iSABEL JAEN TORREJIMENO
- Recruiting
Hospital General Universitario de Castellón
Castellon, Castellón, 12004
Luis GOMEZ-QUILES, luisgomezquiles171261@gmail.com
Luis GOMEZ-QUILES
- Recruiting
Consorcio Hospitalario Provincial de Castellón
Castellon, Castellón, 12006
Enrique BOLDÓ RODA, eboldo@me.com
Enrique BOLDÓ RODA
- Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, Ciudad Real, 13005
Susana SÁNCHEZ GARCÍA, ssanchezgarcia15@gmail.com
Susana SÁNCHEZ GARCÍA
- Recruiting
Hospital Universitario Reina Sofía
Córdoba, Córdoba, 14004
Alvaro ARJONA, alvaroarjona@hotmail.com
Alvaro ARJONA
- Recruiting
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, 30120
Pedro CASCALES CAMPOS, cascalescirugia@gmail.com
Pedro CASCALES CAMPOS
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
Alicia CALERO, alidoc20@yahoo.es
Alicia CALERO
- Recruiting
HOSPITAL UNIVERSITARIO DE FUENLABRADA (Coordinating Centre)
Fuenlabrada, Madrid, 28942
Fernando PEREIRA, PhD, +34916006455, fernando.pereira@salud.madrid.org
Angel SERRANO, PhD
- Recruiting
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Gran Canaria, 35010
Manuel ARTILES, martilesarmas@gmail.com
Manuel ARTILES
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Luis GONZÁLEZ BAYÓN, lgbayon@salud.madrid.org
Luis GONZÁLEZ BAYÓN
- Active, not recruiting
Md Anderson Cancer Center
Madrid, Madrid, 28033
- Recruiting
Hospital Universitario Ramón Y Cajal
Madrid, Madrid, 28034
Julio GALINDO ÁLVAREZ, julio.galindo@salud.madrid.org
Julio GALINDO ÁLVAREZ
- Recruiting
Fundación Jiménez Díaz
Madrid, Madrid, 28040
Pedro VILLAREJO, villarejocampos@yahoo.es
Pedro VILLAREJO
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Juan Jose SEGURA, juanjose.segura@salud.madrid.org
Juan José SEGURA
- Active, not recruiting
Hospital Quirónsalud Málaga
Málaga, Málaga, 29004
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, MÁLAGA, 29010
Joaquín CARRASCO, joakicc@hotmail.com
Joaquín CARRASCO
- Recruiting
Hospital General Universitario Reina Sofía
Murcia, Murcia, 30003
Pedro Antonio PARRA BAÑOS, pedroapb@yahoo.es
Pedro Antonio PARRA BAÑOS
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Estrella TURIENZO, estrella.turienzo@gmail.com
Estrella TURIENZO
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, 07210
Rafael MORALES SORIANO, rafa.morales@telefonica.net
Rafael MORALES SORIANO
- Active, not recruiting
Hospital Universitario Donostia
San Sebastián, Gipuzkoa, 20014
- Recruiting
Hospital Sant Joan Despi Moises Broggi
Sant Joan Despí, Barcelona, 08970
Lana BIJELIC, lbijelic@csi.cat
Lana BIJELIC
- Recruiting
Hospital Universitario Virgen Del Rocío
Seville, Sevilla, 41013
Daniel DÍAZ GÓMEZ, daniel.diaz.gomez.sspa@juntadeandalucia.es
Daniel DÍAZ GÓMEZ
- Recruiting
Hospital Universitario Infanta Elena
Valdemoro, Madrid, 28340
Cristina RIHUETE CARO, crisrihuete@gmail.com
Cristina RIHUETE CARO
- Recruiting
Instituto Valenciano de Oncología
Valencia, Valencia, 46009
Alfonso GARCÍA FADRIQUE, agarciafadrique@gmail.com
Alfonso GARCÍA FADRIQUE
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010
Maria Eugenia BARRIOS CARVAJAL, barriosmariu@gmail.com
Maria Eugenia BARRIOS CARVAJAL
- Recruiting
Hospital Universitario Y Politécnico La Fe
Valencia, Valencia, 46026
Javier VAQUÉ URBANEJA, fjvaque@yahoo.es
Javier VAQUÉ URBANEJA
- Recruiting
Hospital Universitario Río Hortega
Valladolid, Valladolid, 47012
Enrique ASENSIO, easensiodi@saludcastillayleon.es
Enrique ASENSIO
- Recruiting
Hospital Clínico Universitario "Lozano Blesa"
Zaragoza, Zaragoza, 50009
Vicente BORREGO ESTELLA, vicenteborregoestella@gmail.com
Vicente Borrego
About this study
Official title: 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.
Read the 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.
- Conditions
- Peritoneal Carcinomatosis, Colon Cancer
- Being tested
- complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes, complete cytoreductive surgery without HIPEC
- Keywords
- HIPEC, Mitomycin, Colon Neoplasms, Peritoneal metastasis
- Medical subject headings
- Peritoneal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 without HIPECProcedure or surgery
in the arm without HIPEC, only complete cytoreductive surgery will be performed
| Study group | Role | What they receive |
|---|---|---|
| complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes | Active comparator | Not described Receives: Drug: complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes |
| complete cytoreductive surgery without HIPEC | Experimental | Not described Receives: Procedure: complete cytoreductive surgery without HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal Recurrence Free Survival
From the date of surgery to the date of peritoneal recurrence or death, or to the end of follow-up
Measured: 3 years
Secondary outcomes (7)
Global recurrence at any location (Disease Free Survival)
From the date of surgery to the date of recurrence at any site or death
Measured: 3 years
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
Measured: 3 years
Postoperative complications (rate and severity grade)
Using the CTCAE v5.0 adverse event classification system, including those related to HIPEC.
Measured: days 1-90 after surgery
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)
Measured: 3 years
Overall survival
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.
Measured: 3 years
Quality of Life with EORTC validated questionnaire Core 30 (QLQ-C30)
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.
Measured: 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).
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.
Measured: pre-surgery, at the end of postoperative SCT (an average 4-6 months), at 12 months and at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start2 Mar 2022
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Fuenlabrada
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Hospital Universitario La Paz
- Responsible party
- Principal investigator, Fernando Pereira, Hospital Universitario de Fuenlabrada
- Investigators
- Fernando Pereira, PhD, Principal investigator, Hospital Universitario de Fuenlabrada, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250648
- Sponsor's protocol ID
- GECOP-MMC
- Other IDs
- 2019-004679-37, 2019
- Acronym
- GECOP-MMC
- Status last verified
- Oct 2024
- First submitted
- 23 Jan 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35549912
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05250648
- Acronym / sponsor ID
- GECOP-MMC / GECOP-MMC
- Conditions
- Peritoneal Carcinomatosis, Colon Cancer
- Keywords
- HIPEC, Mitomycin, Colon Neoplasms, Peritoneal metastasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Hospital Universitario de FuenlabradaUniversity, hospital or other
- Collaborators
- Instituto de Investigación Hospital Universitario La Paz
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes | Active comparator | Drug: complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes |
| complete cytoreductive surgery without HIPEC | Experimental | Procedure: complete cytoreductive surgery without HIPEC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
- Treatment with perioperative systemic chemotherapy (SCT), before and/or after surgical procedure.
Key exclusion criteria (12 listed)
- 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.
- Disease progression during preoperative chemotherapy, if received.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutesIn 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 | Drug | complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes |
| complete cytoreductive surgery without HIPECin the arm without HIPEC, only complete cytoreductive surgery will be performed | Procedure or surgery | complete cytoreductive surgery without HIPEC |
Primary outcome
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
7 secondary outcomes
Global recurrence at any location (Disease Free Survival)
Time frame: 3 years
Locoregional and distant recurrence rate (isolated or coincident, with or without simultaneous peritoneal recurrence)
Time frame: 3 years
Postoperative complications (rate and severity grade)
Time frame: days 1-90 after surgery
Peritoneal and global recurrence rate according to stratified PCI
Time frame: 3 years
Overall survival
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Results publication: PubMed 35549912Pereira 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.
- Individual participant dataSharing planned: Yes. 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.
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RecruitingPhase 1
A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer or Malignant Peritoneal Mesothelioma
Mesothelin Positive, Mesothelin-Expressing Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando Pereira, PhD principal investigator
Hospital Universitario de Fuenlabrada, Madrid, Spain
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes and complete cytoreductive surgery without HIPEC in people with Peritoneal Carcinomatosis and Colon Cancer, run by Hospital Universitario de Fuenlabrada at 31 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando Pereira, PhD (+34916006455, fernando.pereira@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal Recurrence Free Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05250648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.