REtroperitoneal SArcoma Registry: an International Prospective Initiative

Recruiting now

Conditions studied: Retroperitoneal Sarcoma

In brief

Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority. Primary Objectives of this study are: * to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers. * patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM). Secondary Objectives: * to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS; * to prospectively evaluate the impact of multimodality therapy, including radiation therapy and chemotherapy; * to identify clinical, radiological and pathological characteristics that may influence the oncological outcome or may be used as predictors of LR/DM/OS. These may be important biomarkers of disease; * to utilize collected pathological material for research collaborations.

Key facts

Study ID

NCT03838718

Run by

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

People needed

2000

Starts

2016-09-01

Expected to finish

2030-12-31

Last updated by the study team

2019-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• primary RPS operated on in the participating center;
• age>18 years at the time of the first treatment (pediatric patients can not be included)
• histological confirmed diagnosis according to the WHO criteria done on biopsy or surgical specimen by dedicated sarcoma pathologist;
• radiological examinations performed (contrast enhanced abdominal CT scan and/or MRI) prior to surgical resection;
• signed informed consent form;
• adequate compliance of the patients to the plan of follow-up

You may not qualify if…

• age<18 years;
• recurrent tumor;
• benign retroperitoneal tumors;
• serious psychiatric disease that precludes informed consent or limits compliance;
• impossibility to ensure adequate follow-up

Where it is running

• University of Southern California (USC) — Los Angeles, California, United States (enrolling)
• Mayo Clinic — Jacksonville, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Winship Cancer Institute — Emory, Georgia, United States (enrolling)
• Brigham and Women's Hospital/Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• Peter MacCallum Cancer Center — Melbourne, Australia (enrolling)
• Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology — Warsaw, Poland (enrolling)
• Institute of Oncology Ljubljana — Ljubljana, Slovenia (enrolling)
• University Hospital Birmingham (Queen Elizabeth) — Birmingham, United Kingdom (enrolling)
• Royal Marsden Hospital — London, United Kingdom (enrolling)
• The Ottawa Hospital — Ottawa, Canada (enrolling)
• Mount Sinai / Princess Margaret — Toronto, Canada (enrolling)
• Institut Curie — Paris, France (enrolling)
• Ludwig Maximilian University — Munich, Germany (enrolling)
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (enrolling)
• Veneto Institute of Oncology — Padova, Italy (enrolling)
• Ospedale Borgo Roma — Verona, Italy (enrolling)
• Maisonneuve-Rosemont Hospital / University of Montreal — Montreal, Canada
• University Medical Center and Medical Faculty Mannheim, University of Heidelberg — Mannheim, Germany
• Samsung Medical Center — Seoul, South Korea
• Hospital Clinico Universitario "Virgen de la Arrixaca" — Murcia, Spain

Full record on ClinicalTrials.gov

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