Informations générales (source: ClinicalTrials.gov)
REtroperitoneal SArcoma Registry (RESAR): Prospective Collection of Primary Retroperitoneal Sarcoma Patient's Data, Radiological and Pathological Material for the TransAtlantic Retroperitoneal Sarcoma Working Group (RESAR)
Observational [Patient Registry]
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Voir sur ClinicalTrials)
septembre 2016
décembre 2030
29 juin 2024
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.
Etablissements
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
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CLCC INSTITUT CURIE | Sylvie Bonvalot, MD | Contact (sur clinicalTrials) |
Critères
Tous
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
- 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
- age<18 years;
- recurrent tumor;
- benign retroperitoneal tumors;
- serious psychiatric disease that precludes informed consent or limits compliance;
- impossibility to ensure adequate follow-up