Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies

Recruiting

• Conditions: Mesothelioma; Pseudomyxoma Peritonei; Colorectal Carcinoma; Ovarian Carcinoma
• Interventions: Other: Observational study.

• Registration Number: NCT02073500
• Lead Sponsor: Oslo University Hospital

Brief Summary

The aim of this study is to identify biomarkers of disease recurrence and prognosis to optimize patient selection for treatment with cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC), and through animal models to explore different treatment strategies for peritoneal surface malignancies (PSM).

Detailed Description

The handling of patients with PSM involves multimodal and multidisciplinary treatment strategies such as CRS, the removal of all macroscopically detectable tumor, and HIPEC, instillation of heated chemotherapy in the abdominal cavity to remove residual cancer disease. The treatment is challenging and complex and associated with significant morbidity. Only patients with limited disease will benefit from the treatment, and better methods for patient selection are needed. The project group has a unique opportunity to address key questions because of acquired experience, an exceptional biobank and institutional database and novel animal models established at the Norwegian Radium Hospital.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2014-02-17
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-28
• Primary Completion: 2022-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• age > 18 years
• confirmed diagnosis of peritoneal surface malignancy
• candidate for CRS-HIPEC
• written informed consent

Exclusion Criteria

• none

Approximately 80 patients per year will be eligible for inclusion, as this is the number of patients that annually receive surgical treatment for PSM.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational study	Observational study.	Patients diagnosed with PSM undergoing CRS with HIPEC.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	5 years	Time from surgery until death from any cause

Secondary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	5 years	Time from surgery until disease recurrence or death

Trial Locations

Locations (1)

The Norwegian Radium Hospital; 🇳🇴 Oslo, Norway