Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03280511|
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peritoneum Cancer Peritoneal Carcinomatosis Peritoneal Metastases Colo-rectal Cancer||Drug: PIPAC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Non-randomized, non-blinded phase 2 cohort study|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280511
|Odense PIPAC Center, Department of Surgery, Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: Martin Graversen, MD +45 30549497 email@example.com|
|Principal Investigator: Martin Graversen, MD, Ph.D.|
|Principal Investigator:||Martin Graversen, MD||Odense PIPAC Center|