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.
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;
age<18 years;
recurrent tumor;
benign retroperitoneal tumors;
serious psychiatric disease that precludes informed consent or limits compliance;
Patients diagnosed with a primary RPS amenable to surgical resection.
Cohort
Prospective
Not listed
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.
Overall Survival
Overall Survival computed from date of surgery
Crude cumulative incidence of Local recurrence
CCI of Local recurrence computed from date of surgery, and defined as intrabdominal recurrent disease after complete resection
Crude cumulative incidence of Distant metastasis
CCI of distant metastasis computed from date of surgery, and defined as hepatic recurrence and / or extrabdominal recurrent disease
Morbidity
Postsurgical morbidity according to Clavien-Dindo classification
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
TransAtlantic Retroperitoneal Sarcoma Working Group
Collaborator
