Clinical trial · Interventional
Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol Chemotherapy -
Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol - The PIPAC-OPC2 Trial
NCT03287375CI-TRIAL-00061320PIPAC-OPC2completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study, where the efficacy of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) against peritoneal metastases will be evaluated. Furthermore, this study will focus on the best evaluation method, where both Quality of Life questionnaires, repeated histology, cytology and MRI will be used.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Histologic Progression | — | UNRESOLVED | — |
| Peritoneal Metastases | — | UNRESOLVED | — |
| Peritoneal Neoplasms | Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Peritoneum; Carcinomatosis | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PIPAC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PIPAC
- description
- Peritoneal metastases (PM) from colorectal or appendiceal cancer will be treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) using oxaliplatin 92 mg/m2 in 150 ml dextrose. Peritoneal metastases (PM) from other GI or gynecologic cancers will be treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) using cisplatin 7.5 mg/m2 in 150 ml saline combined with doxorubicin 1.5 mg/m2 in 50 ml saline. PIPAC is performed during a standard laparoscopy with a capnoperitoneum of 12 mmHg and the aerosolised chemotherapy will be nebulized at a maximum pressure of 200 PSI and a flow rate of 0.5 ml/min. There is no upper number of allowed PIPAC treatments, but they will be planned in series of 3 with 4-6 weeks interval (6-7 weeks if combined with systemic chemotherapy).
- interventionNames
- Drug: PIPAC
Primary outcomes (1)
- measure
- Number of patients with major/complete histologic response (PRGS 1+2) peritoneal biopsies, within a series of three PIPAC procedures.
- timeFrame
- 4 years
- description
- Objective Tumor response will be evaluated by the Peritoneal Regression Grading Score based on repeated peritoneal biopsies during each PIPAC procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological verified gastrointestinal-, ovarian- or primary peritoneal malignancy (based on tissue from the primary tumor and/or its metastases). * Ovarian cancer patients must be platinum resistant and have completed at least one line of chemotherapy for platinum resistant disease. * Radiological, histological or cytological evidence of PC. * No indication for CRS and HIPEC (according to National Guidelines). * Performance status 0-1. * No more than a single extra-peritoneal metastasis. * Age \> 18 years. * Females must be post-menopausal * Written informed consent must be obtained according to the local Ethics Committee requirements. Exclusion Criteria: * Symptomatic small bowel obstruction (i.e. total parenteral nutrition, nasogastric tube). * Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones. * A history of allergic reaction to platinum containing compounds or doxorubicin. * Renal impairment, defined as GFR \< 40 ml/min, (Cockcroft-Gault Equation). * Myocardial insufficiency, defined as NYHA class \> 2. * Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit). * Inadequate hematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x109/l.
References
Publications (5)
- BACKGROUNDSolass W, Kerb R, Murdter T, Giger-Pabst U, Strumberg D, Tempfer C, Zieren J, Schwab M, Reymond MA. Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy. Ann Surg Oncol. 2014 Feb;21(2):553-9. doi: 10.1245/s10434-013-3213-1. Epub 2013 Sep 5. PMID 24006094
- BACKGROUNDTempfer CB, Celik I, Solass W, Buerkle B, Pabst UG, Zieren J, Strumberg D, Reymond MA. Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience. Gynecol Oncol. 2014 Feb;132(2):307-11. doi: 10.1016/j.ygyno.2013.11.022. Epub 2013 Nov 23. PMID 24275155
- BACKGROUNDSolass W, Giger-Pabst U, Zieren J, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC): occupational health and safety aspects. Ann Surg Oncol. 2013 Oct;20(11):3504-11. doi: 10.1245/s10434-013-3039-x. Epub 2013 Jun 14. PMID 23765417
- DERIVEDGraversen M, Lundell L, Fristrup C, Pfeiffer P, Mortensen MB. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) as an outpatient procedure. Pleura Peritoneum. 2018 Nov 27;3(4):20180128. doi: 10.1515/pp-2018-0128. eCollection 2018 Dec 1. PMID 30911669
- DERIVEDGraversen M, Detlefsen S, Asmussen J, Mahdi B, Fristrup C, Pfeiffer P, Mortensen MB. Treatment of peritoneal carcinomatosis with Pressurized IntraPeritoneal Aerosol Chemotherapy - PIPAC-OPC2. Pleura Peritoneum. 2018 Jun 9;3(2):20180108. doi: 10.1515/pp-2018-0108. eCollection 2018 Jun 1. PMID 30911656