Feasibility study of adjuvant laparoscopic hyperthermic intraperitoneal chemotherapy in patients with colorectal cancer at high risk of peritoneal carcinomatosis

Phase 2

Completed

• Conditions: 10017991; peritoneal cancer

• Registration Number: NL-OMON36646
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Patients diagnosed with adenocarcinoma of the colon and proximal rectum and at least one of the following risk factors for PC will be considered for inclusion:
* pT4
* (Resected) local peritoneal nodules in the close proximity of the primary tumour
* Primary tumour presenting with obstruction and/or perforation
* Positivie cytology in peritoneal lavage
* Ovarian metastasis or omental metastasis;Eligibility criteria are:
* age between 18 and 75 years,
* ECOG performance status 0 to 2,
* written informed consent obtained prior to any study specific screening procedures,
* white blood cell count at least 3000/mm3, platelet count at least 100.000/mm3,
* no bleeding diathesis or coagulopathy,
* creatinine normal or creatinine clearance at least 50 ml/min

Exclusion Criteria

* liver and/or lung metastases,
* pregnant or lactating women,
* unstable or uncompensated respiratory or cardiac disease,
* serious active infections,
* other concurrent chemotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is hospital stay. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are treatment related morbidity defined as surgical<br /><br>complications and toxicity related to the intraperitoneal chemotherapy. </p><br>