NCT03280511RecruitingPhase 2
Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial
Source: ClinicalTrials.gov · Last updated 6 Oct 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 3 Sept 2017
- Start date
- 14 Dec 2017
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Michael Bau Mortensen
- Diseases
- Colorectal cancer
- NCT number
- NCT03280511
- EU CT number
- 2024-519189-31-00
- EudraCT number
- 2017-002637-37
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 14 Dec 2017 to the primary completion date, 1 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cytoreductive surgery (CRS) with HIPEC
Other illness
- Other malignant diagnosis within the last 2 years
- A history of allergic reaction to oxaliplatin or other platinum containing compounds
- Myocardial insufficiency, defined as NYHA class \> 2.
- Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
Lab values
- Renal impairment, defined as GFR \< 50 ml/min, (Cockcroft-Gault Equation).
- 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.
Other
- Radiologically or clinically proven relapse.
- Contraindications to laparoscopy (e.g. severe adhesions, peritonitis)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.