Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
NCT02073500 · Phase II · Oslo, Norway
- Condition
- Ovarian Cancer
- Disease stage
- Stage I-IV
- Phase
- Phase II
- Study type
- OTHER
- Intervention
- Observational study.
- Age
- 18 Years to
- Gender
- All
- Sponsor
- Oslo University Hospital
- Research institution
- Oslo University Hospital
- Facility
- The Norwegian Radium Hospital
- Research center
- The Norwegian Radium Hospital
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.
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
Overall survival (OS)
Secondary outcomes
Disease-free survival (DFS)