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 (HIPECT4)

Maimónides Biomedical Research Institute of Córdoba

Status and phase: Active, not recruiting; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: MITOMYCIN-C 30 mg; Procedure: Proactive cytoreductive surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02614534

FCO-HIP-2015-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Proactive cytoreductive surgery + HIPEC

Experimental group

Description:

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

Treatment:

Drug: MITOMYCIN-C 30 mg

Proactive cytoreductive surgery

Active Comparator group

Description:

Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women).

Treatment:

Procedure: Proactive cytoreductive surgery