Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol Chemotherapy -

NCT03287375 | Completed Phase 2 DMC

• 1 other identifier: PIPAC-OPC2
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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

Peritoneum; Carcinomatosis; Peritoneal Neoplasms; Peritoneal Metastases; Chemotherapy Effect; Chemotherapeutic Toxicity; Quality of Life; Histologic Progression

Outcome Measures

Primary Outcomes (1)

• Number of patients with major/complete histologic response (PRGS 1+2) peritoneal biopsies, within a series of three PIPAC procedures.

  Objective Tumor response will be evaluated by the Peritoneal Regression Grading Score based on repeated peritoneal biopsies during each PIPAC procedure.

  4 years

Secondary Outcomes (2)

• Number of patients with improved Quality of Life (QoL)

  4 years

• Number of patients where MRI is accurate in describing PM distribution and progressive/regressive disease

  4 years

Study Arms (1)

PIPAC

EXPERIMENTAL

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).

Drug: PIPAC

Interventions

PIPAC DRUG

Also known as: Cisplatin, Doxorubicin, Oxaliplatin

PIPAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael Bau Mortensen: lead

Study Sites (1)

Department of Surgery, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (5)

• Solass 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 BACKGROUND

• Tempfer 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 BACKGROUND

• Solass 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 BACKGROUND

• Graversen 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 DERIVED

• Graversen 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 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Cisplatin; Doxorubicin; Oxaliplatin

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Cohorte study

Study Record Dates

• First Submitted: September 2, 2017
• First Posted: September 19, 2017
• Study Start: December 1, 2016
• Primary Completion: February 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)