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New treatment option for Peritoneal Carcinomatosis
Official title Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)
ClinicalTrials.gov ID: NCT05250648
What this study is testing
What is complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes?
complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peritoneal carcinomatosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed colon adenocarcinoma, except signet ring cell carcinomas (those with \> 50% of the tumor composed of these cells, which...
- Absence of previously treated or current extraperitoneal metastases, including distant lymphadenopathy (retroperitoneal, mediastinal, etc), liver...
- 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.
You likely can't join if
- Peritoneal carcinomatosis of any other origin, particularly rectal cancer or appendicular adenocarcinoma, or signet ring cell colon cancer on...
- No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases of perianastomotic (local) or lymph node (locoregional) recurrences...
- 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.
See the full eligibility criteria
- 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.
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Elche, Alicante, Spain
- Almería, Almería, Spain
- Badajoz, Badajoz, Spain
- Sant Joan Despí, Barcelona, Spain
- Castellon, Castellón, Spain
- Ciudad Real, Ciudad Real, Spain
- Córdoba, Córdoba, Spain
- San Sebastián, Gipuzkoa, Spain
- Las Palmas de Gran Canaria, Gran Canaria, Spain
- Alcalá de Henares, Madrid, Spain
- Alcorcón, Madrid, Spain
- Fuenlabrada, Madrid, Spain
- Madrid, Madrid, Spain
- Valdemoro, Madrid, Spain
- Palma de Mallorca, Mallorca, Spain
- El Palmar, Murcia, Spain
- Murcia, Murcia, Spain
- Málaga, Málaga, Spain
- Oviedo, Principality of Asturias, Spain
- Seville, Sevilla, Spain
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Elche, Alicante, Spain; Almería, Almería, Spain; Badajoz, Badajoz, Spain; Sant Joan Despí, Barcelona, Spain; Castellon, Castellón, Spain; Ciudad Real, Ciudad Real, Spain and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.