---
title: Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma
nct_id: NCT02614534
overall_status: UNKNOWN
phase: PHASE3
sponsor: Maimónides Biomedical Research Institute of Córdoba
study_type: INTERVENTIONAL
primary_condition: Colorectal Cancer
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02614534.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02614534"
ct_last_update_post_date: 2023-09-28
last_seen_at: "2026-05-12T06:35:31.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma

**Official Title:** Multicentre, Randomized Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma

**NCT ID:** [NCT02614534](https://clinicaltrials.gov/study/NCT02614534)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Maimónides Biomedical Research Institute of Córdoba
- **Conditions:** Colorectal Cancer
- **Start Date:** 2015-11-16
- **Completion Date:** 2024-03
- **CT.gov Last Update:** 2023-09-28

## Brief Summary

The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.

## Detailed Description

The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.

The Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) is expected to be an effective treatment with minimal side effects, it has already provided clear benefits in terms of overall survival in patients with advanced cancer.

This is an attractive option for the healthcare professionals who face daily to peritoneal recurrence after performing complex surgeries, however its application is difficult due to the cost and resources increase. This leads to the necessity of administering the treatment within a clinical trials and in order to obtain a significant power this clinical trials will be multicenter and it will be performed in several Oncological surgery Units highly specialised and with extensive experience in colorectal carcinoma.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Male and female patients between the ages of 18 and 75 years;
2. Adenocarcinoma of the colon, sigma and colon-sigma joint which represent cT4a/b in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual;
3. Lymph node involvement: N0, the presence of N1/2 according to the 7th edition of the AJCC is allowed, provided that they can be resectable;
4. Metastatic extent: M0;
5. Karnofsky index \>70 or Performance status ≤2;
6. Informed consent properly completed.

Exclusion Criteria:

1. Presence of metastases (M1), in case of liver or peritoneal metastases at the time of surgery, the patient will be excluded from the trial and treated according to their new stage.
2. Presence of unresectability criteria;
3. Urgent intervention due to obstruction or perforation if there is tumor removal, prior interventions will be accepted as referrals without primary tumor removal or drainage of collections prior to scheduled surgery.
4. Extraperitoneal rectal cáncer (avoiding alterations for neoadyuvance);
5. Coexistence of another malignant neoplastic disease (synchronous tumors of the colon and upper rectum are accepted as long as the stage is equal to or less than the treated tumor).
6. Severely altered liver, kidney and cardiovascular function;
7. Intolerance to treatment;
8. Administration of chemotherapy before the trial (use of neoadyuvance is discarded);
9. Pregnant or breastfeeding women.
```

## Arms

- **Proactive cytoreductive surgery + HIPEC** (EXPERIMENTAL) — Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC (Mytomicin C - 60 minutes).
- **Proactive cytoreductive surgery** (ACTIVE_COMPARATOR) — Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women).

## Interventions

- **MITOMYCIN-C 30 mg** (DRUG) — Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC with Mytomicin C for 60 minutes.
- **Proactive cytoreductive surgery** (PROCEDURE) — Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women)

## Primary Outcomes

- **Locoregional Control (LC)** _(time frame: 3 years)_ — Time elapsed from the surgical intervention clinical up to the date the patient is free of clinical and radiological locoregional recurrence

## Secondary Outcomes

- **Overall survival** _(time frame: 12 months and 36 months after surgery)_
- **Disease Free Survival** _(time frame: 12 months and 36 months after surgery)_
- **Evaluation of the morbidity and mortality related with the treatment** _(time frame: 36 months after surgery)_
- **HIPEC technique operating time** _(time frame: 36 months after surgery)_
- **HIPEC technique length of hospital stay** _(time frame: 36 months after surgery)_
- **HIPEC technique re-admission rate** _(time frame: 36 months after surgery)_
- **HIPEC technique laparoscopic vs laparotomy approach** _(time frame: 36 months after surgery)_
- **HIPEC technique open vs. closed HIPEC technique** _(time frame: 36 months after surgery)_
- **Quality of life questionnaire QLQ-C30** _(time frame: At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery)_
- **Quality of life questionnaires QLQ-CR29** _(time frame: At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery)_

## Locations (19)

- Hospital Universitario Son Espases, Palma de Mallorca, Balearic Islands, Spain
- Hospital de Sant Joan Despí. Moisès Broggi, Sant Joan Despí, Barcelona, Spain
- Hospital Universitario de Gran Canaria "Dr. Negrín", Las Palmas de Gran Canaria, Canary Islands, Spain
- Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Canary Islands, Spain
- Hospital Provincial de Castellón, Castellon, Castellón, Spain
- Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid, Spain
- Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain
- Hospital Universitario Torrecárdenas, Almería, Spain
- Hospital Universitario de Badajoz, Badajoz, Spain
- Hospital General Universitario de Ciudad Real, Ciudad Real, Spain
- Hospital Universitario Reina Sofía, Córdoba, Spain
- MD Anderson Cancer Center, Madrid, Spain
- Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
- Hospital Universitario La Paz, Madrid, Spain
- Hospital Universitario HM Sanchinarro, Madrid, Spain
- Hospital Regional Universitario de Málaga, Málaga, Spain
- Hospital General Universitario Reina Sofía, Murcia, Spain
- Instituto Valenciano de Oncología, Valencia, Spain
- Hospital Clínico Universitario de Valencia, Valencia, Spain

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital universitario son espases|palma de mallorca|balearic islands|spain` — added _(2026-05-12)_
- `locations.hospital de sant joan despí. moisès broggi|sant joan despí|barcelona|spain` — added _(2026-05-12)_
- `locations.hospital universitario de gran canaria "dr. negrín"|las palmas de gran canaria|canary islands|spain` — added _(2026-05-12)_
- `locations.hospital universitario nuestra señora de candelaria|santa cruz de tenerife|canary islands|spain` — added _(2026-05-12)_
- `locations.hospital provincial de castellón|castellon|castellón|spain` — added _(2026-05-12)_
- `locations.hospital universitario príncipe de asturias|alcalá de henares|madrid|spain` — added _(2026-05-12)_
- `locations.hospital universitario de fuenlabrada|fuenlabrada|madrid|spain` — added _(2026-05-12)_
- `locations.hospital universitario torrecárdenas|almería||spain` — added _(2026-05-12)_
- `locations.hospital universitario de badajoz|badajoz||spain` — added _(2026-05-12)_
- `locations.hospital general universitario de ciudad real|ciudad real||spain` — added _(2026-05-12)_
- `locations.hospital universitario reina sofía|córdoba||spain` — added _(2026-05-12)_
- `locations.md anderson cancer center|madrid||spain` — added _(2026-05-12)_
- `locations.hospital universitario fundación jiménez díaz|madrid||spain` — added _(2026-05-12)_
- `locations.hospital universitario la paz|madrid||spain` — added _(2026-05-12)_
- `locations.hospital universitario hm sanchinarro|madrid||spain` — added _(2026-05-12)_
- `locations.hospital regional universitario de málaga|málaga||spain` — added _(2026-05-12)_
- `locations.hospital general universitario reina sofía|murcia||spain` — added _(2026-05-12)_
- `locations.instituto valenciano de oncología|valencia||spain` — added _(2026-05-12)_
- `locations.hospital clínico universitario de valencia|valencia||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02614534.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02614534*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*