Catheter based adjuvant intraperitoneal chemotherapy for carcinomatosis.
Phase 1
- Conditions
- carcinomatosisTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 17.0Level: LLTClassification code 10007506Term: CarcinomatosisSystem Organ Class: 100000004864
- Registration Number
- EUCTR2014-000882-34-BE
- Lead Sponsor
- niversity Hospital Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
-Peritoneal carcinomatosis from GI origin (appendix, colon, small bowel, stomach)
-Resectable disease
-No or minimal systemic or extra-abdominal disease or metastatic spread
-Written informed consent
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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
Exclusion Criteria
-Comorbidity that precludes surgery and/or IP chemotherapy
-Irresectable disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the feasibility and safety of adjuvant, catheter based intraperitoneal chemotherapy in patients with minimal residual disease after cytoreductive surgery for carcinomatosis from GI origin.;Secondary Objective: Not applicable;Primary end point(s): termination of IP chemotherapy due to complications or adverse events.;Timepoint(s) of evaluation of this end point: until end oif treatment due to complications or adverse events
- Secondary Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable