EUCTR2015-001801-15-ES
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- FIBICO
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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