Treating Peritoneal Carcinomatosis With PIPAC
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|ClinicalTrials.gov Identifier: NCT02320448|
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : September 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Carcinomatosis||Drug: PIPAC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implementation and Evaluation of PIPAC for the Treatment of Patients With Peritoneal Carcinomatosis - a Feasibility Study.|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
PIPAC with cisplatin (7.5mg/m2 in 150 ml saline) and doxorubicin (1.5mg/m2 in 50 ml saline) in patients with peritoneal metastases (PM) from any origin besides colorectal/appendiceal cancers in whom oxaliplatin (92mg/m2 in 150 ml dextrose) will be used.
The aerosolised chemotherapy will be nebulized at a flow of 0.5ml/min at a maximum pressure of 200 PSI during a standard laparoscopy with an intraabdominal pressure of 12mmHg. The CO2 will be evacuated 30 minutes after administration of chemotherapy and the patient is closed similar to a standard laparoscopy.
- Number of Patients with Adverse Events. [ Time Frame: 5 months. ]No patients with adverse events above grade 3 on the CTCAE (Version 4) scale. No patients with complications above grade 2 on the Dindo-Clavien classification.
- Occupational health. [ Time Frame: 5 months. ]No detectable chemotherapy on environmental biomonitoring and blood samples from the surgeons and OR staff.
- Feasibility: Completion of procedure in 28:35 [ Time Frame: 5 months. ]Completion of procedure in 28:35.
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): NCT02320448
|Odense University Hospital|
|Odense, Denmark, 5000|
|Study Director:||Michael Mortensen, Professor||Odense University Hospital|