Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
Recruiting
Phase 2Interventional Study
Peritoneum CancerPeritoneal CarcinomatosisPeritoneal MetastasesColo-rectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
60 (estimated)
Sponsor
Michael Bau Mortensen · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility 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 u…
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
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