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REtroperitoneal SArcoma Registry: an International Prospective Initiative (RESAR)

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ClinicalTrials.gov Identifier: NCT03838718
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
TransAtlantic Retroperitoneal Sarcoma Working Group
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Condition or disease
Retroperitoneal Sarcoma

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: REtroperitoneal SArcoma Registry (RESAR): Prospective Collection of Primary Retroperitoneal Sarcoma Patient's Data, Radiological and Pathological Material for the TransAtlantic Retroperitoneal Sarcoma Working Group
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Disease-free Survival [ Time Frame: 10 years ]
    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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 10 years ]
    Overall Survival computed from date of surgery

  2. Crude cumulative incidence of Local recurrence [ Time Frame: 10 years ]
    CCI of Local recurrence computed from date of surgery, and defined as intrabdominal recurrent disease after complete resection

  3. Crude cumulative incidence of Distant metastasis [ Time Frame: 10 years ]
    CCI of distant metastasis computed from date of surgery, and defined as hepatic recurrence and / or extrabdominal recurrent disease

  4. Morbidity [ Time Frame: 60 days ]
    Postsurgical morbidity according to Clavien-Dindo classification


Biospecimen Retention:   Samples Without DNA
Biopsies, Surgical specimen


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with a primary RPS amenable to surgical resection.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838718


Contacts
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Contact: Alessandro Gronchi, MD +39022390 ext 3234 alessandro.gronchi@istitutotumori.mi.it
Contact: Marco Fiore, MD +392390 ext 2910 marco.fiore@istitutotumori.mi.it

  Show 22 Study Locations
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
TransAtlantic Retroperitoneal Sarcoma Working Group
Investigators
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Principal Investigator: Alessandro Gronchi, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Director: Marco Fiore, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Additional Information:
Publications:
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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT03838718     History of Changes
Other Study ID Numbers: 201/16
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
Sarcoma
Surgery
Multivisceral resection
Chemotherapy
Radiation Therapy
Patients' Registry

Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms