Colorectal Cancer with Metastases in the Peritoneum Colorectal Peritoneal Carcinomatosis
Conditions
Interventions
Besides regular treatment with palliative systemic chemotherapy, patients will
also receive three PIPAC-surgeries with oxaliplatin during a 9 week interval.
Each 0 week interval starts with 2-3 cycl
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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. Patients treated with (neo-)adjuvant chemotherapy are able to enrol in the study if this treatment was finished >6 months before trial enrolment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major toxicity, defined as grade >2 according to the Common Terminology Criteria for Adverse Events v4.0, and measured up to four weeks after the last PIPAC procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mild to moderate toxicity, defined as grade 1-2 according to the Common Terminology Criteria for Adverse Events v4.0, and measured up to four weeks after the last PIPAC procedure. - The completed amount of cycles of bi-directional therapy with PIPAC and systemic chemotherapy - The completed amount of cycles of systemic chemotherapy; the amount dose reductions, and reasons for dose reductions. - Intra operative characteristics of PIPAC with oxaliplatin (e.g. laparoscopic access rate, ascites volume, blood loss) - Intra operative complications during PIPAC with oxaliplatin (e.g. bowel perforation, bleeding) - Length of hospital stay during bi-directional therapy with PIPAC and systemic chemotherapy - Readmission rate during bi-directional therapy with PIPAC and systemic chemotherapy - To determine nephrotoxicity, hepatotoxicity, and haematological toxicity of bi-directional therapy with PIPAC and systemic chemotherapy - To determine tumour markers (CEA) during bi-directional therapy with PIPAC and systemic chemotherapy - To determine macroscopic tumour respons during bi-directional therapy with PIPAC and systemic chemotherapy - To determine histopathological tumour resonse of tumour tissue and ascites collected during second and third PIPAC - To determine quality of life during bi-directional therapy with PIPAC and systemic chemotherapy - To determine intraperitoneal and systemic progression free survival after bi-directional therapy with PIPAC and systemic chemotherapy - To determine overall survival after bi-directional therapy with PIPAC and systemic chemotherapy - To collect blood and frozen tissue for translational research - To determine the systemic pharmacokinetics of oxaliplatin after one cycle of systemic chemotherapy and one PIPAC. | — |
Countries
Netherlands
Outcome results
None listed