Randomized study comparing surgery and local chemotherapy versus standard chemotherapy in the treatment of colorectal carcinomatosis.
- Conditions
- Resectable colorectal carcinomatosis.MedDRA version: 14.1Level: LLTClassification code 10050035Term: Metastatic colon cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004058-27-IT
- Lead Sponsor
- ISTITUTO ONCOLOGICO VENETO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 122
• 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
• 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 <40%) • Evidence of renal disease (creatinine level >1.5 than the normal institutional limits or creatinine clearance <60 mL/min) • Evidence of hepatic disease (ASAT, ALAT, bilirubin >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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.