REtroperitoneal SArcoma Registry: an International Prospective Initiative

Description

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.

Conditions

Retroperitoneal Sarcoma

Study Overview

Study Details

Study overview

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.

REtroperitoneal SArcoma Registry (RESAR): Prospective Collection of Primary Retroperitoneal Sarcoma Patient's Data, Radiological and Pathological Material for the TransAtlantic Retroperitoneal Sarcoma Working Group

REtroperitoneal SArcoma Registry: an International Prospective Initiative

Condition
Retroperitoneal Sarcoma
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California (USC), Los Angeles, California, United States, 90033

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Emory

Winship Cancer Institute, Emory, Georgia, United States, 30322

Boston

Brigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02115

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano,

Alessandro Gronchi, MD, PRINCIPAL_INVESTIGATOR, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Marco Fiore, MD, STUDY_DIRECTOR, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Record Dates

2030-12-31