Multicentre Phase IV clinical trial to evaluate the efficacy of hyperthermic intraoperative chemotherapy (HIPEC) with Mitomycin-C after complete surgical debulking in patients with peritoneal metastases of colon cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Universitario De Fuenlabrada

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 Feb 2022 → ongoing

Decision date (initial)

2024-05-07

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512726-28-00

EudraCT number

2019-004679-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate whether there are differences in PERITONEAL RECURRENCE in patients with Colon Cancer Peritoneal Metastases treated with complete surgical resection and QTS, with (Group 1) or without (Group 2) HIPEC with Mitomycin-C.

Secondary objectives 6

1. To evaluate if there are differences in overall recurrence (at any location) between both groups (Disease Free Survival). GECOP-MMC Protocol v13.0 09/23/2022
2. To evaluate the toxicity of the treatments and compare postoperative complications between the two groups
3. Determine prognostic factors for peritoneal and other levels of recurrence.
4. To compare Overall Survival between both groups.
5. Study of Quality of Life in both groups using the EORTC QLQ-C30 and QLQ-CR29 questionnaires.
6. Correlation between surgical and pathological PCI, comparing their respective prognostic values (complementary study).

Conditions and MedDRA coding

peritoneal metastases of colorectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Histologically proven colon cancer, except those with signet ring cells (those with > 50% of the tumor composed of such cells, which only account for 1% of CRC).
2. Absence of current or previously treated extraperitoneal metastases, including distant adenopathies (retroperitoneal, mediastinal,...), liver metastases, or pulmonary metastases (ruled out by PET in case of doubt).
3. Synchronous or metachronous peritoneal carcinomatosis of mild or moderate extension, with a PCI ≤ 20 (APPENDIX I) (intraoperative evaluation).
4. Obtaining a macroscopically complete surgical cytoreduction CCS-0 (intraoperative evaluation).
5. Treatment with perioperative systemic chemotherapy (before and/or after the surgical procedure).
6. Age > 18 years.
7. Acceptable anesthetic/surgical risk: ASA 1-3 (APPENDIX II), ECOG 0-1 (APPENDIX III), hematological, renal and hepatic function without severe alterations (operable patients).
8. Information to the patient and signature of the study-specific Informed Consent.

Exclusion criteria 12

1. Peritoneal carcinomatosis of any other origin, in particular rectal cancer or appendiceal adenocarcinoma, or signet ring cell colon cancer on histology.
2. No intraoperative confirmation of peritoneal disease (PCI 0). Cases of perianastomotic (local) or lymph node (locoregional) recurrence will also be excluded.
3. High volume peritoneal carcinomatosis, with a PCI > 20 (APPENDIX I), or incomplete cytoreduction (intraoperative evaluation).
4. Concurrent or previously treated extraperitoneal disease.
5. Progression during preoperative chemotherapy, if received.
6. Patients previously treated with HIPEC.
7. History of other cancers (except cutaneous basal cell carcinoma or carcinoma in situ of the cervix) in the 5 years prior to study entry.
8. Patient included in another first-line clinical trial for the disease studied.
9. Pregnancy (or suspected pregnancy) or lactation period.
10. Urgent intervention for obstruction or perforation of a primary tumor with synchronous MP (although salvage or secondary CR + HIPEC after emergency surgery of the primary tumor are acceptable if the inclusion criteria are met).
11. Persons deprived of liberty or under guardianship.
12. Inability to understand the nature of the intervention, the risks, benefits, expected evolution and need to undergo periodic medical examinations, either for geographical, social or psychological reasons.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. peritoneal recurrence-free survival at 1, 2 and 3 years.

Secondary endpoints 7

1. Overall recurrence (ORS) at 1, 2 and 3 years.
2. Locoregional and distant recurrence (isolated or coincident, with or without simultaneous peritoneal recurrence) at 1, 2, and 3 years.
3. Postoperative complications using the CTCAE v5.0 90-day adverse event classification system, including those related to HIPEC.
4. Prognostic factors for peritoneal and global recurrence: synchronous/metachronous PM, perioperative QTS, use of biological agents or immunotherapy, stratified PCI (1-10, 11-15, 16-20), postoperative complications, right/left colon, degree of differentiation, vascular/lymphatic/perineural invasion, RAS/RAF status, microsatellite instability and degree of peritoneal tumour regression.
5. Overall survival at 1, 2 and 3 years.
6. Study of Quality of Life in both groups using the EORTC QLQ-C30 and QLQ-CR29 questionnaires (APPENDIX IV), to be carried out at the aforementioned times.
7. Correlation surgical PCI - pathological PCI

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitario De Fuenlabrada

Sponsor organisation

Hospital Universitario De Fuenlabrada

Address

Camino Del Molino 2

City

Fuenlabrada

Postcode

28942

Country

Spain

Scientific contact point

Organisation

Hospital Universitario De Fuenlabrada

Contact name

Fernando Pereira

Public contact point

Organisation

Hospital Universitario De Fuenlabrada

Contact name

Fernando Pereira

Locations

1 EU/EEA country · 31 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications