Repetitive cycles of combination treatment consisting of three cycles of regular chemotherapy followed by a PIPAC-surgery for the treatment of irresectable peritoneal metastases from colorectal cancer: feasibility, safety, tolerability, efficacy.
- Conditions
- Isolated peritoneal metastases (PM) from colorectal cancer (CRC)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002290-63-NL
- Lead Sponsor
- Catharina Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 20
- 18 years or older
- Histologically confirmed PM from a colorectal (including appendiceal) carcinoma that are not amenable for complete cytoreductive surgery, as determined by laparotomy, laparoscopy or radiology.
- WHO performance score of 0-1
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
-Radiological evidence of systemic metastatic disease (e.g. liver, lung);
-Symptomatic presentation (e.g. non-deviated obstructive symptoms);
-Histologically confirmed PM from a low grade appendiceal carcinoma (Disseminated Peritoneal Adeno-Mucinosis / Low-grade Appendiceal Mucinous Neoplasm);
-Inadequate organ functions, defined as an Hb of <5.0 mmol/L, an absolute neutrophil count of <1.5 x 10^9/L, platelet count of <100 x 10^9/L, serum creatinine of >1.5 x ULN, creatinine clearance (Cockroft formula) of <30 ml/min, and liver transaminases of >5 x ULN;
-Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, uncompensated cardiac disease, coagulopathy, serious active infections), as determined by the medical oncologist;
-Any contraindication for a laparoscopy, as determined by the surgeon and/or anesthesiologist;
-Previous PIPAC-procedures;
-Previous treatment with palliative systemic chemotherapy (Note: this criterium does not include patients that received systemic chemotherapy in a (neo-)adjuvant setting).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method