Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05250648

Phase IV Multicentric Clinical Trial to Evaluate the Efficacy of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Mitomycin-C After Complete Surgical Cytoreduction in Patients With Colon Cancer Peritoneal Metastases

Led by Hospital Universitario de Fuenlabrada · Updated on 2024-10-09

216

Participants Needed

31

Research Sites

N/A

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

Researchers are evaluating whether adding Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Mitomycin C after complete surgical removal of peritoneal metastases in patients with colon cancer affects the chance of cancer returning in the abdomen. This phase IV clinical trial addresses uncertainties from prior research by focusing on the time patients remain free from peritoneal recurrence rather than overall survival. It excludes rectal cancers and patients with extensive peritoneal disease or incomplete surgery to better understand HIPEC's role in this setting. Participants are randomly assigned to one of two groups: one receiving complete cytoreductive surgery plus HIPEC with Mitomycin C delivered at 35 mg/m2 in a heated peritoneal dialysis solution for 90 minutes with dose fractionation, and the other receiving surgery alone without HIPEC. The study corrects previous trial shortcomings by increasing HIPEC infusion time and limiting patient selection based on cancer spread and surgery completeness. During the trial, participants will be monitored for peritoneal recurrence over three years, with assessments including imaging and disease-free survival measures. Researchers will also track postoperative complications within 90 days after surgery and evaluate quality of life at multiple points: before surgery, after chemotherapy, and at one and two years. The trial aims to provide detailed information on recurrence patterns, survival, and patient well-being over three years following treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed colon adenocarcinoma, excluding signet ring cell carcinomas with more than 50% of those cells
  • No previously treated or current extraperitoneal metastases including distant lymph nodes, liver, or lung
  • Synchronous or metachronous peritoneal metastasis with peritoneal cancer index (PCI) of 20 or less
  • Macroscopically complete surgical cytoreduction (CCS-0)
  • Treatment with systemic chemotherapy before and/or after surgery
  • Age over 18 years
  • Acceptable anesthetic and surgical risk (ASA 1-3) and good performance status (ECOG 0-1)
  • Informed consent signed and patient informed about the study
Not Eligible

You will not qualify if you...

  • Peritoneal carcinomatosis from other origins, including rectal cancer, appendicular adenocarcinoma, or signet ring cell colon cancer
  • No intraoperative confirmation of peritoneal disease (PCI 0) or local/lymph node recurrences
  • High volume peritoneal disease with PCI over 20
  • Concurrent or previously treated extraperitoneal disease
  • Disease progression during preoperative chemotherapy
  • Previous treatment with HIPEC
  • History of other cancers (except basal cell skin cancer or cervix carcinoma in situ) within 5 years
  • Participation in another first-line clinical trial for this disease
  • Pregnancy, suspected pregnancy, or breastfeeding
  • Emergency surgery for obstruction or perforation with synchronous peritoneal metastases
  • Persons deprived of liberty or under legal/administrative supervision
  • Inability to understand the intervention, risks, benefits, or need for follow-up due to geographic, social, or psychological reasons

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day plus up to 90 days post-operative period

Participants undergo complete cytoreductive surgery. Depending on the assigned group, some participants will also receive Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Mitomycin C administered for 90 minutes during surgery.

Approximately 3 months of post-operative monitoring visits

Follow-up

Duration - Up to 3 years

Participants are monitored for recurrence and survival outcomes, as well as quality of life assessments over three years following surgery.

Visits at pre-surgery, end of postoperative systemic chemotherapy (average 4-6 months), 12 months, 24 months, and regular assessments up to 3 years

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

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Research Team

F

Fernando Pereira, PhD

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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Published Research Related To This Trial

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.

Fernando Pereira, Angel Serrano, Israel Manzanedo...

https://pubmed.ncbi.nlm.nih.gov/35549912