Catheter based adjuvant intraperitoneal chemotherapy for carcinomatosis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000882-34-BE

Enrollment

Registered

2014-05-05

Start date

2014-06-03

Completion date

Unknown

Last updated

2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carcinomatosis MedDRA version: 17.0 Level: LLT Classification code 10007506 Term: Carcinomatosis System Organ Class: 100000004864

Interventions

Trade Name: Fluracedyl 50 mg/ml, oplossing voor injectie Pharmaceutical Form: Solution for infusion INN or Proposed INN: 5-fluorouracil Other descriptive name: 5-FLOUROURACIL Concentration unit: mg/ml

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - Comorbidity that precludes surgery and/or IP chemotherapy - Irresectable disease

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Belgium

Contacts

Public ContactBimetra Clinics

University Hospital Ghent

bimetra.clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026