REtroperitoneal SArcoma Registry: an International Prospective Initiative (RESAR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03838718|
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
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).
- 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|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|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|
- 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.
- Overall Survival [ Time Frame: 10 years ]Overall Survival computed from date of surgery
- 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
- 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
- Morbidity [ Time Frame: 60 days ]Postsurgical morbidity according to Clavien-Dindo classification
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838718
|Contact: Alessandro Gronchi, MD||+39022390 ext email@example.com|
|Contact: Marco Fiore, MD||+392390 ext firstname.lastname@example.org|
Show 22 Study Locations
|Principal Investigator:||Alessandro Gronchi, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|
|Study Director:||Marco Fiore, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|