Pre treatment with chemotherapy followed by surgery and removal of all intra-abdominal tumor and intra-peritoneal heated chemotherapy for peritoneal metastastasized colorectal cancer.

Neo-adjuvant chemotherapy, cytoreductive surgery with hyperthermic intra-peritoneal chemotherapy for peritoneal carcinomatosis of colorectal origin (NACHO-trial) - NACHO-trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020787-37-NL

Enrollment

Registered

2011-11-30

Start date

2013-01-28

Completion date

Unknown

Last updated

2013-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peritoneal carcinomatosis of colorectal origin

Interventions

Trade Name: Capecitabine Product Name: Capecitabine Pharmaceutical Form: Tablet INN or Proposed INN: CAPECITABINE CAS Number: 154361-50-9 Concentration unit: mg/m2 milligram(s)/square meter Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Peritoneal carcinomatosis of colorectal origin diagnosed either at laparotomy or by malignant ascites on CT-scan. When ascites is diagnosed cytologic confirmation of peritoneal carcinomatosis is sufficient. At laparotomy either histologic or cytologic confirmation of peritoneal carcinomatosis is sufficient. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Age under 18 Previous chemotherapy History of other malignancy Advanced liver disease, Child-Pugh score>B WHO performance status above 2. Unable to give written informed consent. Creatinine clearance below 30 ml/min Liver or extra abdominal metastases Neurotoxicity > grade 2 according CTC AE 3.0

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety of neo-adjuvant chemotherapy using the CAPOX scheme followed by cytoreductive surgery and HIPEC with mitomycin C in patients with peritoneal carcinomatotosis of colorectal origin.;Secondary Objective: 1)The response of peritoneal carcinomatosis to chemotherapy according to RECIST criteria and postoperative pathological examination 2) 30-day or in-hospital mortality following CRS+HIPEC after neo-adjuvant chemotherapy. 3) Quality of life as measured by the EORTC-QLQ C30 quality of life questionnaire 4) morbidity of surgery according to the NCI-CTC v3.0 5) The effect of chemotherapy and CRS with HIPEC on intestinal barrier function as measured by IFAB levels. 6) The percentage of patients able to complete full treatment ;Primary end point(s): 30-day or in-hospital mortality following CRS+HIPEC after neo-adjuvant chemotherapy;Timepoint(s) of evaluation of this end point: 30-days after surgery	—

Measure

Time frame

Main Objective: To evaluate the safety of neo-adjuvant chemotherapy using the CAPOX scheme followed by cytoreductive surgery and HIPEC with mitomycin C in patients with peritoneal carcinomatotosis of colorectal origin.;Secondary Objective: 1)The response of peritoneal carcinomatosis to chemotherapy according to RECIST criteria and postoperative pathological examination 2) 30-day or in-hospital mortality following CRS+HIPEC after neo-adjuvant chemotherapy. 3) Quality of life as measured by the EORTC-QLQ C30 quality of life questionnaire 4) morbidity of surgery according to the NCI-CTC v3.0 5) The effect of chemotherapy and CRS with HIPEC on intestinal barrier function as measured by IFAB levels. 6) The percentage of patients able to complete full treatment ;Primary end point(s): 30-day or in-hospital mortality following CRS+HIPEC after neo-adjuvant chemotherapy;Timepoint(s) of evaluation of this end point: 30-days after surgery

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Secondary

Measure	Time frame
Secondary end point(s): 1)The response of peritoneal carcinomatosis to chemotherapy according to RECIST criteria and postoperative pathological examination 2) 30-day or in-hospital mortality following CRS+HIPEC after neo-adjuvant chemotherapy. 3) Quality of life as measured by the EORTC-QLQ C30 quality of life questionnaire 4) Morbidity of surgery according to the NCI-CTC v3.0 5) The effect of chemotherapy and CRS with HIPEC on intestinal barrier function as measured by IFAB levels. 6) The percentage of patients able to complete full treatment ;Timepoint(s) of evaluation of this end point: 30 days after surgery	—

Measure

Time frame

Secondary end point(s): 1)The response of peritoneal carcinomatosis to chemotherapy according to RECIST criteria and postoperative pathological examination 2) 30-day or in-hospital mortality following CRS+HIPEC after neo-adjuvant chemotherapy. 3) Quality of life as measured by the EORTC-QLQ C30 quality of life questionnaire 4) Morbidity of surgery according to the NCI-CTC v3.0 5) The effect of chemotherapy and CRS with HIPEC on intestinal barrier function as measured by IFAB levels. 6) The percentage of patients able to complete full treatment ;Timepoint(s) of evaluation of this end point: 30 days after surgery

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Countries

Netherlands

Contacts

Public ContactRobert van Ginkel

University Medical Center Groningen

r.j.van.ginkel@chir.umcg.nl0031503612283

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026