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

This study is not yet open for participant recruitment.
Verified October 2017 by Michael Bau Mortensen, Odense University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03280511
First Posted: September 12, 2017
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Bau Mortensen, Odense University Hospital
  Purpose
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.

Condition Intervention Phase
Peritoneum Cancer Peritoneal Carcinomatosis Peritoneal Metastases Colo-rectal Cancer Drug: PIPAC Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Non-randomized, non-blinded phase 2 cohort study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial

Resource links provided by NLM:


Further study details as provided by Michael Bau Mortensen, Odense University Hospital:

Primary Outcome Measures:
  • The number of patients with peritoneal recurrence [ Time Frame: 3 years ]
    Based on contrast enhanced CT of the thorax and abdomen 36 months after resection of high-risk colon cancer.


Secondary Outcome Measures:
  • The number of conversions from positive to negative peritoneal lavage cytology [ Time Frame: 5 weeks ]
    Peritoneal lavage cytology will be performed during each PIPAC treatment in order to detect free intraperitoneal tumor cells. Interval of 5 weeks between each PIPAC.

  • Number of patients where the planned PIPAC procedures are completed [ Time Frame: 5 weeks ]
    Two PIPAC procedures are planned.

  • Number of patients with treatment related toxicity or complications [ Time Frame: 3 months ]
    Based on CTCAE (vers. 4.0) and Dindo-Clavien´s surgical complications assessment.

  • 1- and 2-year peritoneal recurrence free survival [ Time Frame: 2 years ]
    Based on CT of the thorax and abdomen performed 12- and 24 months after primary resection

  • 1-, 2- and 3-year recurrence free survival, [ Time Frame: 3 years ]
    Based on CT of the thorax and abdomen performed 12-, 24 and 36 months after primary resection

  • 1-, 3- and 5-year overall survival rate [ Time Frame: 5 years ]
    Based on the Danish Civil Registration System


Estimated Enrollment: 60
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: March 1, 2025
Estimated Primary Completion Date: October 1, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional
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
PIPAC is performed during a standard laparoscopy with a capnoperitoneum of 12 mmHg. During PIPAC, oxaliplatin 92 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
Other Name: Oxaliplatin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280511


Locations
Denmark
Odense PIPAC Center, Department of Surgery, Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Contact: Martin Graversen, MD    +45 30549497    martin.graversen@rsyd.dk   
Principal Investigator: Martin Graversen, MD, Ph.D.         
Sponsors and Collaborators
Michael Bau Mortensen
Investigators
Principal Investigator: Martin Graversen, MD Odense PIPAC Center
  More Information

Publications:
Responsible Party: Michael Bau Mortensen, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03280511     History of Changes
Other Study ID Numbers: PIPAC-OPC3
First Submitted: September 3, 2017
First Posted: September 12, 2017
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The database will be used for publications and presentations by the study group.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colonic Neoplasms
Carcinoma
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Rectal Diseases
Oxaliplatin
Antineoplastic Agents