Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies

Colorectal Carcinoma Clinical Trial

— PSM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02073500
• Other study ID #: PSM_250913
• Status: Recruiting
• Start date: September 2009
• Est. completion date: August 2027

Study information

• Verified date: July 2021
• Source: Oslo University Hospital
• Contact: Kjersti Flatmark, MD PhD
• Phone: +47 22 93 40 00
• Email: Kjersti.Flatmark[@]rr-research.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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 / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2027
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• Mesothelioma
• Neoplasms
• Ovarian Carcinoma
• Peritoneal Neoplasms
• Pseudomyxoma Peritonei

Intervention

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.

Locations

Country	Name	City	State
Norway	The Norwegian Radium Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Time from surgery until death from any cause	5 years
Secondary	Disease-free survival (DFS)	Time from surgery until disease recurrence or death	5 years