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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03838718




Registration number
NCT03838718
Ethics application status
Date submitted
29/03/2018
Date registered
12/02/2019
Date last updated
12/02/2019

Titles & IDs
Public title
REtroperitoneal SArcoma Registry: an International Prospective Initiative
Scientific 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
Secondary ID [1] 0 0
201/16
Universal Trial Number (UTN)
Trial acronym
RESAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retroperitoneal Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
10 years
Secondary outcome [1] 0 0
Overall Survival - Overall Survival computed from date of surgery
Timepoint [1] 0 0
10 years
Secondary outcome [2] 0 0
Crude cumulative incidence of Local recurrence - CCI of Local recurrence computed from date of surgery, and defined as intrabdominal recurrent disease after complete resection
Timepoint [2] 0 0
10 years
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
10 years
Secondary outcome [4] 0 0
Morbidity - Postsurgical morbidity according to Clavien-Dindo classification
Timepoint [4] 0 0
60 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
Canada
State/province [6] 0 0
Montréal
Country [7] 0 0
Canada
State/province [7] 0 0
Ottawa
Country [8] 0 0
Canada
State/province [8] 0 0
Toronto
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Germany
State/province [10] 0 0
Mannheim
Country [11] 0 0
Germany
State/province [11] 0 0
Munich
Country [12] 0 0
Italy
State/province [12] 0 0
Milan
Country [13] 0 0
Italy
State/province [13] 0 0
Padova
Country [14] 0 0
Italy
State/province [14] 0 0
Verona
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Poland
State/province [16] 0 0
Warsaw
Country [17] 0 0
Slovenia
State/province [17] 0 0
Ljubljana
Country [18] 0 0
Spain
State/province [18] 0 0
Murcia
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Birmingham
Country [20] 0 0
United Kingdom
State/province [20] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
TransAtlantic Retroperitoneal Sarcoma Working Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT03838718
Trial related presentations / publications
Gronchi A, Strauss DC, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honoré 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.
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.
MacNeill AJ, Gronchi A, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honoré 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.
Public notes

Contacts
Principal investigator
Name 0 0
Alessandro Gronchi, MD
Address 0 0
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alessandro Gronchi, MD
Address 0 0
Country 0 0
Phone 0 0
+39022390
Fax 0 0
Email 0 0
alessandro.gronchi@istitutotumori.mi.it
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03838718