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

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. Identifier: NCT03280511
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : December 15, 2017
Information provided by (Responsible Party):
Michael Bau Mortensen, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Peritoneum Cancer Peritoneal Carcinomatosis Peritoneal Metastases Colo-rectal Cancer Drug: PIPAC Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
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
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
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.
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

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

  3. 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.

  4. 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

  5. 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

  6. 1-, 3- and 5-year overall survival rate [ Time Frame: 5 years ]
    Based on the Danish Civil Registration System

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT03280511

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Odense PIPAC Center, Department of Surgery, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Martin Graversen, MD    +45 30549497   
Principal Investigator: Martin Graversen, MD, Ph.D.         
Sponsors and Collaborators
Michael Bau Mortensen
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Principal Investigator: Martin Graversen, MD Odense PIPAC Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Michael Bau Mortensen, Professor, Odense University Hospital Identifier: NCT03280511    
Other Study ID Numbers: PIPAC-OPC3
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peritoneal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases
Antineoplastic Agents