REtroperitoneal SArcoma Registry: an International Prospective Initiative

Part of paid clinical trials in Los Angeles, California.

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study ID
NCT03838718
Status
Recruiting
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Conditions

  • Retroperitoneal Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Sep 1, 2016
Status verified
Feb 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2030

Study Design

Enrollment
2,000 participants (estimated)

Primary Outcome Measure

Disease-free Survival [ Time Frame: 10 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Southern California (USC)Los AngelesCalifornia90033
William Tseng, MD
[email protected]
Mayo ClinicJacksonvilleFlorida32224
Sanjay Bagaria, MD
[email protected]
Moffitt Cancer CenterTampaFlorida33612
John Mullinax, MD
[email protected]
Winship Cancer InstituteEmoryGeorgia30322
Kenneth Cardona, MD
[email protected]
Brigham and Women's Hospital/Dana-Farber Cancer InstituteBostonMassachusetts02115
Chan Raut, MD
[email protected]
The Ohio State UniversityColumbusOhio43210
Raphael Pollock, MD
[email protected]

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By research site
University of Southern California (USC)· Los Angeles, CAMayo Clinic· Jacksonville, FLMoffitt Cancer Center· Tampa, FLWinship Cancer Institute· Emory, GABrigham and Women's Hospital/Dana-Farber Cancer Institute· Boston, MAThe Ohio State University· Columbus, OH

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