Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients

NCT03280511 | Recruiting Phase 2 DMC

• 1 other identifier: PIPAC-OPC3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peritoneum Cancer; Peritoneal Carcinomatosis; Peritoneal Metastases; Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• The number of patients with peritoneal recurrence

  Based on contrast enhanced CT of the thorax and abdomen 36 months after resection of high-risk colon cancer.

  3 years

Secondary Outcomes (6)

• The number of conversions from positive to negative peritoneal lavage cytology

  5 weeks

• Number of patients where the planned PIPAC procedures are completed

  5 weeks

• Number of patients with treatment related toxicity or complications

  3 months

• 1- and 2-year peritoneal recurrence free survival

  2 years

• 1-, 2- and 3-year recurrence free survival,

  3 years

Study Arms (1)

Interventional

EXPERIMENTAL

Eligible candidates will be enrolled according to in-/exclusion criteria. Two months after colon resection or immediately after adjuvant chemotherapy (if indicated), a standard laparoscopy including peritoneal lavage, peritoneal biopsies and PIPAC treatment with oxaliplatin 92 mg/m2 will be planned. This procedure will be repeated after another 5 weeks. Follow up CTs after 12, 24 and 36 months will be planned.

Drug: PIPAC

Interventions

PIPAC DRUG

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

Also known as: Oxaliplatin

Interventional

Eligibility Criteria

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

You may qualify if:

• 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
• Fertile women must use approved contraceptives (see below)
• Age \> 18 years
• Written informed consent

You may not qualify if:

• Radiologically or clinically proven relapse.
• Previous cytoreductive surgery (CRS) with HIPEC
• Other malignant diagnosis within the last 2 years
• Contraindications to laparoscopy (e.g. severe adhesions, peritonitis)
• A history of allergic reaction to oxaliplatin or other platinum containing compounds
• Renal impairment, defined as GFR \< 50 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 haematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
• Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.

Sponsors & Collaborators

• Michael Bau Mortensen: lead

Study Sites (1)

Odense PIPAC Center, Department of Surgery, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Related Publications (4)

• van Gestel YR, de Hingh IH, van Herk-Sukel MP, van Erning FN, Beerepoot LV, Wijsman JH, Slooter GD, Rutten HJ, Creemers GJ, Lemmens VE. Patterns of metachronous metastases after curative treatment of colorectal cancer. Cancer Epidemiol. 2014 Aug;38(4):448-54. doi: 10.1016/j.canep.2014.04.004. Epub 2014 May 17.

  PMID: 24841870 BACKGROUND

• 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

• Demtroder C, Solass W, Zieren J, Strumberg D, Giger-Pabst U, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy with oxaliplatin in colorectal peritoneal metastasis. Colorectal Dis. 2016 Apr;18(4):364-71. doi: 10.1111/codi.13130.

  PMID: 26400556 BACKGROUND

• Graversen M, Detlefsen S, Fristrup C, Pfeiffer P, Mortensen MB. Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in resected high-risk colon cancer patients - study protocol for the PIPAC-OPC3 Trial. A prospective, controlled phase 2 Study. Pleura Peritoneum. 2018 Jun 12;3(2):20180107. doi: 10.1515/pp-2018-0107. eCollection 2018 Jun 1.

  PMID: 30911655 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms; Colonic Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Martin Graversen, MD

  Odense PIPAC Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Non-randomized, non-blinded phase 2 cohort study

Study Record Dates

• First Submitted: September 3, 2017
• First Posted: September 12, 2017
• Study Start: December 14, 2017
• Primary Completion: October 1, 2024
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)