Actively Recruiting
Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)
Led by Hospital Universitario de Fuenlabrada · Updated on 2024-10-09
216
Participants Needed
31
Research Sites
395 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitario de Fuenlabrada
Lead Sponsor
I
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colon adenocarcinoma, except signet ring cell carcinomas (those with > 50% signet ring cells).
- No previously treated or current metastases outside the peritoneum, including distant lymph nodes, liver, or lungs.
- Presence of synchronous or metachronous peritoneal metastases with a Peritoneal Cancer Index (PCI) of 20 or less, confirmed during surgery.
- Complete surgical cytoreduction with no visible tumor remaining (CCS-0), confirmed during surgery.
- Planned treatment with systemic chemotherapy before and/or after surgery.
- Age over 18 years.
- Acceptable surgical and anesthetic risk (ASA class 1-3, ECOG performance status 0-1).
- No severe blood, kidney, heart, lung, or liver problems making surgery unsafe.
- Patient has been informed about the study and has signed a specific informed consent form.
You will not qualify if you...
- Peritoneal carcinomatosis from origins other than colon cancer, including rectal cancer, appendiceal adenocarcinoma, or signet ring cell colon carcinoma.
- No confirmed peritoneal disease during surgery (PCI 0), or presence of local or regional lymph node recurrences.
- High volume peritoneal disease with PCI greater than 20.
- Presence of current or previously treated metastases outside the peritoneum.
- Disease progression while receiving preoperative chemotherapy.
- Previous treatment with HIPEC.
- History of other cancers within the past 5 years, except for basal cell skin cancer or cervix carcinoma in situ.
- Participation in another first-line clinical trial for the same disease.
- Pregnancy or breastfeeding.
- Emergency surgery for bowel obstruction or perforation with synchronous peritoneal metastases (except if rescue surgery later meets criteria).
- Being under legal supervision or deprived of liberty.
- Inability to understand the study and the need for regular medical follow-up due to social, geographic, or psychological reasons.
AI-Screening
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Trial Site Locations
Total: 31 locations
1
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Actively Recruiting
2
Hospital Universitario Torrecárdenas
Almería, Almería, Spain, 04009
Actively Recruiting
3
Complejo Hospitalario Universitario de Badajoz
Badajoz, Badajoz, Spain, 6080
Actively Recruiting
4
Hospital Sant Joan Despi Moises Broggi
Sant Joan Despí, Barcelona, Spain, 08970
Actively Recruiting
5
Hospital General Universitario de Castellón
Castellon, Castellón, Spain, 12004
Actively Recruiting
6
Consorcio Hospitalario Provincial de Castellón
Castellon, Castellón, Spain, 12006
Actively Recruiting
7
Hospital General Universitario de Ciudad Real
Ciudad Real, Ciudad Real, Spain, 13005
Actively Recruiting
8
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain, 14004
Actively Recruiting
9
Hospital Universitario Donostia
San Sebastián, Gipuzkoa, Spain, 20014
Active, Not Recruiting
10
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35010
Actively Recruiting
11
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain, 28805
Actively Recruiting
12
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
Actively Recruiting
13
HOSPITAL UNIVERSITARIO DE FUENLABRADA (Coordinating Centre)
Fuenlabrada, Madrid, Spain, 28942
Actively Recruiting
14
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
15
Md Anderson Cancer Center
Madrid, Madrid, Spain, 28033
Active, Not Recruiting
16
Hospital Universitario Ramón Y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
17
Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
Actively Recruiting
18
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
19
Hospital Universitario Infanta Elena
Valdemoro, Madrid, Spain, 28340
Actively Recruiting
20
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, Spain, 07210
Actively Recruiting
21
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
22
Hospital General Universitario Reina Sofía
Murcia, Murcia, Spain, 30003
Actively Recruiting
23
Hospital Quirónsalud Málaga
Málaga, Málaga, Spain, 29004
Active, Not Recruiting
24
Hospital Regional Universitario de Málaga
Málaga, MÁLAGA, Spain, 29010
Actively Recruiting
25
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
26
Hospital Universitario Virgen Del Rocío
Seville, Sevilla, Spain, 41013
Actively Recruiting
27
Instituto Valenciano de Oncología
Valencia, Valencia, Spain, 46009
Actively Recruiting
28
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
29
Hospital Universitario Y Politécnico La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
30
Hospital Universitario Río Hortega
Valladolid, Valladolid, Spain, 47012
Actively Recruiting
31
Hospital Clínico Universitario "Lozano Blesa"
Zaragoza, Zaragoza, Spain, 50009
Actively Recruiting
Research Team
F
Fernando Pereira, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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