Clinical trial NCT02073500: Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
Official title: Prospective Observational Study of Peritoneal Surface Malignancies (PSM) - Characterization, Models and Treatment Strategies.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pseudomyxoma Peritonei
Colorectal Carcinoma
Ovarian Carcinoma
Mesothelioma
Keywords: Peritoneal carcinomatosis
Peritoneal surface malignancy
Cytoreductive surgery
Hyperthermic intraperitoneal chemotherapy
CRS
HIPEC
Prognostic biomarker
Predictive biomarker
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2014-02-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with PSM that are referred to Oslo University Hospital and are candidates for CRS with HIPEC may be included in the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
Secondary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: The Norwegian Radium Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kjersti Flatmark, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lund-Andersen C, Nakken S, Nygard S, Fromm B, Aasheim LB, Davidson B, Julsrud L, Abrahamsen TW, Kristensen AT, Dybdahl B, Larsen SG, Hovig E, Flatmark K. Integrative genomic analysis of peritoneal malignant mesothelioma: understanding a case with extraordinary chemotherapy response. Cold Spring Harb Mol Case Stud. 2019 Apr 1;5(2):a003566. doi: 10.1101/mcs.a003566. Print 2019 Apr.