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REtroperitoneal SArcoma Registry: an International Prospective Initiative

NCT03838718 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2019-02-12

No results posted yet for this study

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

Sponsors & Collaborators

  • TransAtlantic Retroperitoneal Sarcoma Working Group

    collaborator UNKNOWN

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Alessandro Gronchi, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  • Marco Fiore, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2020-12-31
Completion
2030-12-31

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Italy
  • Poland
  • Slovenia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03838718 on ClinicalTrials.gov