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Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies

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).

Tracking Information
First Received DateFebruary 17, 2014
Last Changed DateOctober 14, 2015
Start DateSeptember 2009
Anticipated Primary Completion DateJanuary 2017
Primary Outcome Measures

Overall survival (OS) [Time Frame: 5 years]

Secondary Outcome Measures

Progression-free survival (PFS) [Time Frame: 5 years]

Descriptive Information
PhaseN/A
Study TypeObservational [Patient Registry]
Condition
  • Pseudomyxoma Peritonei.
  • Colorectal Carcinoma.
  • Ovarian Carcinoma.
  • Mesothelioma.
Intervention
  • Other: Observational study.
Study Arms / Comparison Groups0 / 1
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.

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment200
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Kjersti Flatmark, MD PhD
Email: Kjersti.Flatmark@rr-research.no
Phone: +47 22 78 18 73
Eligibility Criteria

Inclusion Criteria:

- age > 18 years

- confirmed diagnosis of peritoneal surface malignancy

- candidate for CRS-HIPEC

- written informed consent

Exclusion Criteria:

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

Administrative Information
NCTIDNCT02073500
Responsible Party,
SponsorOslo University Hospital
Verification DateOctober 2015
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