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

• Conditions: Colorectal cancer; MedDRA version: 18.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001801-15-ES
• Lead Sponsor: FIBICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-09
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 o rPerformance status ?2;
6) Informed consent properly completed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1) Presence of metastatasis (M1);
2) Presence of unresectability criteria;
3) Urgent intervention for obstruction or perforation;
4) Extraperitoneal rectal cáncer (avoiding alterations for neoadyuvance);
5) Coexistence with another malignant neoplastic disease;
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified