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Clinical Trials/2024-519189-31-00
2024-519189-31-00RecruitingPhase 2

Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in resected high risk colon cancer patients. - The PIPAC-OPC3 CC trial,

Odense University Hospital1 site in 1 country60 target enrollmentStarted: December 3, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
The proportion of patients with peritoneal recurrence on contrast enhanced CT of the thorax and abdomen 36 months after resection of high-risk colon cancer
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

As PIPAC seems to have an effect on visible peritoneal metastasis in colon cancer patients, we hypothesize that PIPAC can minimize the risk of PM recurrence in resected high risk colon cancer patients. The main objective of this trial is to test this hypothesis.

Study Design

Allocation
Non-randomized
Primary Purpose
Pipac Ox
Masking
None

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Radically resected colon cancer patients with adeno- or signet ring cell carcinomas with high-risk tumors defined as: perforated / pT4NanyM0 (UICC 8th edition) / pTanyNanyM1 with radically resected PM including ovarian metastases
  • •Performance status 0-1
  • •Age > 18 years

Exclusion Criteria

  • •Radiologically or clinically proven relapse.
  • •Previous cytoreductive surgery (CRS) with HIPEC
  • •Other malignant diagnosis within the last 2 years

Outcomes

Primary Outcomes

The proportion of patients with peritoneal recurrence on contrast enhanced CT of the thorax and abdomen 36 months after resection of high-risk colon cancer

The proportion of patients with peritoneal recurrence on contrast enhanced CT of the thorax and abdomen 36 months after resection of high-risk colon cancer

Secondary Outcomes

  • Treatment related toxicity and complication rate
  • Completion rate of two adjuvant PIPAC treatments
  • 1- and 2-year peritoneal recurrence free survival, based on CT of the thorax and abdomen
  • 1-, 2- and 3-year recurrence free survival, based on CT of the thorax and abdomen
  • 1-, 3- and 5-year overall survival rate
  • The number of conversions from positive to negative peritoneal lavage cytology after one PIPAC procedure

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Clinical trial mail address

Scientific

Odense University Hospital

Study Sites (1)

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