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NCT03868228

PIPAC for the Treatment of Colorectal Peritoneal Metastases

Status unknown Phase 1, PHASE2 Last updated 28 September 2022
What this trial tests

Phase 1, PHASE2 trial testing Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) in Colorectal Neoplasms in 30 participants. Status unknown.

Timeline
5 February 2019
Primary endpoint
30 September 2024
30 September 2024

Quick facts

Lead sponsorImperial College London
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date5 February 2019
Primary completion30 September 2024
Estimated completion30 September 2024
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Imperial College London

Who can join

18 and older, any sex, with Colorectal Neoplasms or Peritoneal Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study would like to assess the efficacy of pressurised intraperitoneal aerosol chemotherapy (PIPAC). This technique delivers chemotherapy directly into the abdomen via a less invasive laparoscopic or 'keyhole' form of surgery. This type of chemotherapy takes the form of an aerosol, similar to the spray of a deodorant for example. The aerosol is administered into the abdomen under pressure, pushing the chemotherapy deeper into the tissues and cancer. This approach does not involve any surgical removal of the cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-OX) in patients with colorectal peritoneal metastases-a systematic review.
    Lurvink RJ, Rovers KP, Nienhuijs SW, Creemers GJ, et al · · 2021 · cited 26× · PMID 33968441 · DOI 10.21037/jgo-20-257
  2. The emergence of pressurized intraperitoneal aerosol chemotherapy as a palliative treatment option for patients with diffuse peritoneal metastases: a narrative review.
    Lurvink RJ, Van der Speeten K, Rovers KP, de Hingh IHJT. · · 2021 · cited 18× · PMID 33968442 · DOI 10.21037/jgo-20-497
  3. PIPAC for Gastrointestinal Malignancies.
    Daniel SK, Sun BJ, Lee B. · · 2023 · cited 15× · PMID 37959264 · DOI 10.3390/jcm12216799
  4. Patient-reported outcomes during repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy for isolated unresectable colorectal peritoneal metastases in a multicenter, single-arm, phase 2 trial (CRC-PIPAC).
    Lurvink RJ, Rovers KP, Wassenaar ECE, Bakkers C, et al · · 2022 · cited 12× · PMID 34757489 · DOI 10.1007/s00464-021-08802-6
  5. First-line palliative systemic therapy alternated with electrostatic pressurised intraperitoneal aerosol chemotherapy (oxaliplatin) for isolated unresectable colorectal peritoneal metastases: protocol of a multicentre, single-arm, phase II study (CRC-PIPAC-II).
    Lurvink RJ, Rauwerdink P, Rovers KP, Wassenaar ECE, et al · · 2021 · cited 11× · PMID 33785492 · DOI 10.1136/bmjopen-2020-044811
  6. UK trial of pressurised intraperitoneal aerosolised chemotherapy (PIPAC) with oxaliplatin for colorectal cancer peritoneal metastases (NCT03868228).
    Kyle P, Perry K, Moutadjer A, Gilfillan N, et al · · 2023 · cited 4× · PMID 38144217 · DOI 10.1515/pp-2023-0008
  7. Is PIPAC a Treatment Option in Upper and Lower Gastrointestinal Cancer with Peritoneal Metastasis?
    Guel-Klein S, Alberto Vilchez ME, Ceelen W, Rau B, et al · · 2022 · cited 3× · PMID 35614892 · DOI 10.1159/000523901
  8. Physiological Considerations and Delivery Strategies for Targeting Tumors Through Intraperitoneal Delivery.
    Jony MJH, Ranjbar S, Prajapati R, Eslami SM, et al · · 2025 · cited 2× · PMID 40855029 · DOI 10.1007/s11095-025-03917-0

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