CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 60 target
Drug / intervention
PIPACdrug
Likely dose
PIPAC 46 mg/m2from record
Key inclusion· 4
  • ✓Radically resected colon cancer with adenocarcinoma or signet ring cell carcinoma
  • ✓High-risk tumors: perforated, pT4 any N M0, or pTany NanyM1 with radically resected peritoneal metastases including ovarian metastases
  • ✓Age greater than 18 years
  • ✓Written informed consent
Key exclusion· 5
  • ✕Radiologically or clinically proven relapse
  • ✕Previous cytoreductive surgery with HIPEC
  • ✕Other malignant diagnosis within last 2 years
  • ✕Contraindications to laparoscopy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03280511
NCT03280511Phase 2RecruitingUpdate OverdueUpdated 44mo ago · Completion was 20mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial

Michael Bau Mortensen·interventional·Posted Sep 12, 2017·Updated Oct 6, 2022

In Brief

A Phase 2 clinical trial evaluating PIPAC for Peritoneum Cancer and 3 related conditions. Currently recruiting, targeting 60 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

In this study, patients will be offered two Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) treatments with oxaliplatin after primary resection and standard adjuvant chemotherapy (if indicated) for colon cancer. Furthermore, the study will explore, whether it is possible to find free intraperitoneal tumor cells (FITC) after resection and adjuvant chemotherapy for colon cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeritoneum Cancer, Peritoneal Carcinomatosis, Peritoneal Metastases, Colo-rectal Cancer
CountriesDenmark
Collaborators--

Timeline

Phase 2Recruiting
2018201920202021202220232024202520262027
First PostedSep 12, 2017
Enrollment StartDec 14, 2017
Primary CompletionOct 1, 2024
Study CompletionMar 1, 2027
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 8.8 years ago

Interventions

PIPACdrug

PIPAC is performed during a standard laparoscopy with a capnoperitoneum of 12 mmHg. During PIPAC, oxaliplatin 46 mg/m2 in 150 ml dextrose will be intraperitoneally nebulized at a rate of 0.5 ml/s with a maximum pressure of 200 PSI. The intraperitoneal air will be evacuated after 30 minutes of simple diffusion