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.|
|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|
Show Detailed Description
|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
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
|Odense PIPAC Center, Department of Surgery, Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: Martin Graversen, MD +45 30549497 firstname.lastname@example.org|
|Principal Investigator: Martin Graversen, MD, Ph.D.|
|Principal Investigator:||Martin Graversen, MD||Odense PIPAC Center|