Colorectal cancer MedDRA version: 18.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: MITOMYCIN-C 10 mg Polvo para solución inyectable
MITOMYCIN-C 40 mg Polvo para solución inyectable
Product Name: MITOMYCIN-C 10 mg Polvo para solución inyectable MITOMYCIN-C 40 mg Polvo par
Sponsors
FIBICO
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma;Secondary Objective: 1) To evaluate the effect on the overall survival (OS) at 12 months and 3 years of adding Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery 2) To evaluate the effect on the disease-free survival rates (DFS) at 12 months and 3 years of adding Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery 3) To evaluate safety (morbidity and mortality) of adding Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery;Primary end point(s): Locoregional Control (LC) in months and the 12 months and 3 years Locoregional Control Rate (LC %);Timepoint(s) of evaluation of this end point: 12 months and 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Peri and post-operative morbidity through Common Terminology Criteria for Adverse Events (CTCAE) and peri-operative mortality, up to 30 and 90 days after surgery 2) Overall survival (OS) in months and and Overall survival rate (% OS at 12 months and 3 years) 3) Disease-free survival rates (DFS) in months and Disease-free survival rates (% DFS at 12 months and 3 years);Timepoint(s) of evaluation of this end point: 30 and 90 days 12 months and 3 years | — |
Countries
Spain
Contacts
Public ContactBlanca Quijano Ruiz
FIBICO
Outcome results
None listed