PSM: Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies

Sponsor

Oslo University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02073500

Collaborator

The Research Council of Norway (Other)

300

Enrollment

Location

215

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pseudomyxoma Peritonei Colorectal Carcinoma Ovarian Carcinoma Mesothelioma	Other: Observational study.

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Observational Study of Peritoneal Surface Malignancies (PSM) - Characterization, Models and Treatment Strategies.

Actual Study Start Date :

Sep 1, 2009

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Observational study Patients diagnosed with PSM undergoing CRS with HIPEC.	Other: Observational study. Analysis of metastatic tissue and blood specimens collected from patients with PSM undergoing CRS-HIPEC. CRS: Removal of all macroscopically detectable tumor. HIPEC: Instillation of heated chemotherapy in the abdominal cavity to remove residual cancer disease. Other Names: Observational study. Laboratory biomarker analysis.

Arm

Intervention/Treatment

Observational study

Patients diagnosed with PSM undergoing CRS with HIPEC.

Other: Observational study.

Analysis of metastatic tissue and blood specimens collected from patients with PSM undergoing CRS-HIPEC. CRS: Removal of all macroscopically detectable tumor. HIPEC: Instillation of heated chemotherapy in the abdominal cavity to remove residual cancer disease.

Other Names:

Observational study. Laboratory biomarker analysis.

Outcome Measures

Primary Outcome Measures

Overall survival (OS) [5 years]
Time from surgery until death from any cause

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.