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Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02073500
Acronym
PSM
Enrollment
300
Registered
2014-02-27
Start date
2009-09-30
Completion date
2027-08-31
Last updated
2021-07-28

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

Conditions

Colorectal Carcinoma, Mesothelioma, Ovarian Carcinoma, Pseudomyxoma Peritonei

Keywords

Peritoneal carcinomatosis, Peritoneal surface malignancy, Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy, CRS, HIPEC, Prognostic biomarker, Predictive biomarker

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.

Interventions

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.

Sponsors

The Research Council of Norway
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall survival (OS)5 yearsTime from surgery until death from any cause

Secondary

MeasureTime frameDescription
Disease-free survival (DFS)5 yearsTime from surgery until disease recurrence or death

Countries

Norway

Contacts

Primary ContactKjersti Flatmark, MD PhD
Kjersti.Flatmark@rr-research.no+47 22 93 40 00
Backup ContactAnnette Torgunrud Kristensen, PhD
atj@rr-research.no+47 22 78 19 45

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026