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PIPAC for Peritoneal Metastases of Colorectal Cancer

NCT03246321 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-10-15

No results posted yet for this study

Summary

This is multicentre, open-label, single-arm phase II study that investigates the feasibility, safety, tolerability, preliminary efficacy, costs, and pharmacokinetics or repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC-OX) as a palliative monotherapy for patients with isolated unresectable colorectal peritoneal metastases.

Conditions

  • Colorectal Neoplasms
  • Peritoneal Neoplasms
  • Appendiceal Neoplasms
  • Peritoneal Carcinomatosis

Interventions

COMBINATION_PRODUCT

repetitive ePIPAC-OX

Instead of standard palliative treatment, enrolled patients receive laparoscopy-controlled electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) (92 mg/m2 body-surface area \[BSA\]) with intravenous leucovorin (20 mg/m2 BSA) and bolus 5-fluorouracil (400 mg/m2 BSA) every six weeks. Four weeks after each procedure, patients undergo clinical, radiological, and biochemical evaluation. ePIPAC-OX is repeated until clinical, radiological, or macroscopic disease progression, after which standard palliative treatment is (re)considered.

Sponsors & Collaborators

  • Koen Rovers

    lead OTHER

Principal Investigators

  • Ignace de Hingh, MD, PhD · Catharina Hospital, Eindhoven, Netherlands

  • Djamila Boerma, MD, PhD · St Antonius Hospital, Nieuwegein, Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2019-10-01
Completion
2019-10-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246321 on ClinicalTrials.gov