NCT03838718

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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
11 countries

22 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Sep 2016Dec 2030

Study Start

First participant enrolled

September 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2018

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

4.3 years

First QC Date

March 29, 2018

Last Update Submit

February 11, 2019

Conditions

Keywords

SarcomaSurgeryMultivisceral resectionChemotherapyRadiation TherapyPatients' Registry

Outcome Measures

Primary Outcomes (1)

  • Disease-free Survival

    Survival after surgery for primary RPS resection; any disease recurrence, local or distant, will be considered as an event at time of first radiological appearance.

    10 years

Secondary Outcomes (4)

  • Overall Survival

    10 years

  • Crude cumulative incidence of Local recurrence

    10 years

  • Crude cumulative incidence of Distant metastasis

    10 years

  • Morbidity

    60 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with a primary RPS amenable to surgical resection.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

University of Southern California (USC)

Los Angeles, California, 90033, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Winship Cancer Institute

Emory, Georgia, 30322, United States

RECRUITING

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

Boston, Massachusetts, 02115, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, 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, 20133, Italy

RECRUITING

Veneto Institute of Oncology

Padua, 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

Related Publications (6)

  • Gronchi A, Strauss DC, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honore C, Fairweather M, Cannell A, Jakob J, Haas RL, Szacht M, Fiore M, Casali PG, Pollock RE, Raut CP. Variability in Patterns of Recurrence After Resection of Primary Retroperitoneal Sarcoma (RPS): A Report on 1007 Patients From the Multi-institutional Collaborative RPS Working Group. Ann Surg. 2016 May;263(5):1002-9. doi: 10.1097/SLA.0000000000001447.

    PMID: 26727100BACKGROUND
  • Trans-Atlantic RPS Working Group. Management of primary retroperitoneal sarcoma (RPS) in the adult: a consensus approach from the Trans-Atlantic RPS Working Group. Ann Surg Oncol. 2015 Jan;22(1):256-63. doi: 10.1245/s10434-014-3965-2. Epub 2014 Oct 15.

    PMID: 25316486BACKGROUND
  • MacNeill AJ, Gronchi A, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honore C, Fairweather M, Cannell A, Jakob J, Haas RL, Szacht M, Fiore M, Casali PG, Pollock RE, Barretta F, Raut CP, Strauss DC. Postoperative Morbidity After Radical Resection of Primary Retroperitoneal Sarcoma: A Report From the Transatlantic RPS Working Group. Ann Surg. 2018 May;267(5):959-964. doi: 10.1097/SLA.0000000000002250.

    PMID: 28394870BACKGROUND
  • Benuzzi L, Iadecola S, Fiore M, Baia M, Colombo C, Radaelli S, Di Blasi E, Morosi C, Sanfilippo R, Callegaro D, Gronchi A. Pancreaticoduodenectomy and IVC resection in retroperitoneal sarcoma: Expanding the limits of feasible surgery. Eur J Surg Oncol. 2026 Jan;52(1):110547. doi: 10.1016/j.ejso.2025.110547. Epub 2025 Oct 26.

  • Xiao M, Li X, Bu F, Ma S, Yang X, Chen J, Zhao Y, Cananzi F, Luo C, Min L. Molecular feature-based classification of retroperitoneal liposarcoma: a prospective cohort study. Elife. 2025 May 23;14:RP100887. doi: 10.7554/eLife.100887.

  • Zhao Y, Qin D, Li X, Wang T, Zhang T, Rao X, Min L, Wan Z, Luo C, Xiao M. Identification of NINJ1 as a novel prognostic predictor for retroperitoneal liposarcoma. Discov Oncol. 2024 May 11;15(1):155. doi: 10.1007/s12672-024-01016-x.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsies, Surgical specimen

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Alessandro Gronchi, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    PRINCIPAL INVESTIGATOR
  • Marco Fiore, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

February 12, 2019

Study Start

September 1, 2016

Primary Completion

December 31, 2020

Study Completion (Estimated)

December 31, 2030

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations