Recruiting

Observational Study

Sponsor:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Code:

NCT03838718

Conditions

Retroperitoneal Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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 ID

NCT03838718

Start date

Sep 1, 2016

Status verified date

Feb, 2019

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Disease-free Survival [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Alessandro Gronchi, MD

+39022390alessandro.gronchi@istitutotumori.mi.it

Marco Fiore, MD

+392390marco.fiore@istitutotumori.mi.it

Locations

University of Southern California (USC)

Recruiting

Los Angeles, California, United States, 90033

Contacts

William Tseng, MD

William.Tseng@med.usc.edu

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Sanjay Bagaria, MD

Bagaria.sanjay@mayo.edu

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

John Mullinax, MD

John.Mullinax@moffitt.org

Winship Cancer Institute

Recruiting

Emory, Georgia, United States, 30322

Contacts

Kenneth Cardona, MD

ken.cardona@emory.edu

Brigham and Women's Hospital/Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Chan Raut, MD

craut@bwh.harvard.edu

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Raphael Pollock, MD

Raphael.Pollock@osumc.edu

The Ottawa Hospital

Recruiting

Ottawa, Canada

Contacts

Carolyn Nessim, MD

cnessim@toh.ca

Mount Sinai / Princess Margaret

Recruiting

Toronto, Canada

Contacts

Carol Swallow, MD

Carol.Swallow@sinaihealthsystem.ca

More Information

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Last update posted

Feb 12, 2019

Last verified

Feb, 2019

Keywords

  • Sarcoma
  • Surgery
  • Multivisceral resection
  • Chemotherapy
  • Radiation Therapy
  • Patients' Registry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano on 2019-02-12.