Resectable colorectal carcinomatosis. MedDRA version: 14.1 Level: LLT Classification code 10050035 Term: Metastatic colon cancer System Organ Class: 100000004864
Conditions
Interventions
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: MITOMYCIN C
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CISPLATIN
CAS Number: 15663-27-1
Sponsors
ISTITUTO ONCOLOGICO VENETO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically documented colorectal carcinomatosis • Minor/moderate peritoneal carcinomatosis with a Peritoneal Cancer Index (PCI) lower than 20 evaluated by CT and/or PET CT imaging • Patient between age 18 and 75 years. • ECOG 1-2 • ASA score 1-2 • Clinical, instrumental and biohumoral signs of bone marrow, hepatic, renal, pulmonary or cardiac insufficiency absent • Patients must be available for follow up • Signed Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
Exclusion criteria: • Extra-peritoneal metastatic localization (retroperitoneum, lymphnodes, liver or lung) • Prior first-line chemotherapy treatment for peritoneal carcinomatosis(adjuvant therapy excluded) • Prior intraperitoneal chemohyperthermic (HIPEC) treatment • Positive history of malignancies for at least 3 years, with the exception of basal cell carcinoma • Evidence of cardiovascular disease (history of congestive heart failure or LVEF 1.5 than the normal institutional limits or creatinine clearance 1.5 than the normal institutional limits, PT) • Evidence of hematopoietic disease (WBC <4000/mm3; neutrophil count <1500/mm3; platelets < 80000/mm3) • Evidence of pulomonary disease (BPCO or other restrictive lung disease with FEV1 <50% or a DLCO <40% than the normal limits for age)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the role of cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy compared to standard chemotherapy in term of overall survival.;Secondary Objective: Evaluate disease-free survival, toxicity of two treatments and their impact on quality of life.;Primary end point(s): Overall survival from randomization.;Timepoint(s) of evaluation of this end point: 6 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Disease-free survival from randomization • Evaluated of treatment toxicity according to the NCI-CTCAE v.4 • Quality of life with EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires, and HADS Concern Checklist;Timepoint(s) of evaluation of this end point: • Disease-free survival from randomization: 6 years. • Toxicity: until third year. • Quality of life: 1 years. | — |
Countries
Italy
Contacts
Public ContactSperimentazioni Cliniche e Biostat.
Istituto Oncologico Veneto - IRCCS
Outcome results
None listed