International registry for patients with retroperitoneal sarcoma
REtroperitoneal SArcoma Registry (RESAR): Prospective Collection of Primary Retroperitoneal Sarcoma Patient's Data, Radiological and Pathological Material for the TransAtlantic Retroperitoneal Sarcoma Working Group
This study is collecting information and samples from patients with retroperitoneal sarcoma who have surgery to see how well different treatments work and how they affect survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 22 sites (Los Angeles, California and 21 other locations) |
| Trial ID | NCT03838718 on ClinicalTrials.gov |
What this trial studies
This initiative aims to prospectively collect standardized clinical data and biological samples from patients with primary retroperitoneal sarcoma (RPS) who undergo surgical treatment at specialized centers. The study will evaluate patient outcomes, including overall survival and disease-free survival, while also assessing the efficacy and safety of surgical interventions and multimodal therapies like chemotherapy and radiation. By focusing on a rare disease with high local recurrence rates, the study seeks to enhance understanding and treatment approaches for RPS.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a histologically confirmed diagnosis of primary retroperitoneal sarcoma who are undergoing surgical treatment.
Not a fit: Patients with recurrent tumors, benign retroperitoneal tumors, or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could lead to improved treatment strategies and outcomes for patients with retroperitoneal sarcoma.
How similar studies have performed: While there have been retrospective studies on retroperitoneal sarcoma, this prospective approach is relatively novel and aims to fill gaps in existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Los Angeles, California and 21 other locations
- University of Southern California (USC) — Los Angeles, California, United States (Recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Winship Cancer Institute — Emory, Georgia, United States (Recruiting)
- Brigham and Women's Hospital/Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- Peter MacCallum Cancer Center — Melbourne, Australia (Recruiting)
- Maisonneuve-Rosemont Hospital / University of Montreal — Montreal, Canada (Not_yet_recruiting)
- The Ottawa Hospital — Ottawa, Canada (Recruiting)
- Mount Sinai / Princess Margaret — Toronto, Canada (Recruiting)
- Institut Curie — Paris, France (Recruiting)
- University Medical Center and Medical Faculty Mannheim, University of Heidelberg — Mannheim, Germany (Not_yet_recruiting)
- Ludwig Maximilian University — Munich, Germany (Recruiting)
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (Recruiting)
- Veneto Institute of Oncology — Padova, Italy (Recruiting)
- Ospedale Borgo Roma — Verona, Italy (Recruiting)
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology — Warsaw, Poland (Recruiting)
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Not_yet_recruiting)
- Hospital Clinico Universitario "Virgen de la Arrixaca" — Murcia, Spain (Not_yet_recruiting)
- University Hospital Birmingham (Queen Elizabeth) — Birmingham, United Kingdom (Recruiting)
- Royal Marsden Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alessandro Gronchi, MD — Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Study coordinator: Alessandro Gronchi, MD
- Email: alessandro.gronchi@istitutotumori.mi.it
- Phone: +39022390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.