Clinical trial NCT02793050: Retrospective Study of Trabectedin in Soft Tissue Sarcomas
Official title: Trabectedin in Soft Tissue Sarcomas. A Retrospective Observational Analysis (TrObs)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma, Soft Tissue
Keywords: Trabectedin
Soft Tissue Sarcoma
Observational
Lead sponsor: Italian Sarcoma Group
Sponsor class: NETWORK
First posted: 2016-06-08
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced soft tissue sarcoma who received trabectedin according its market authorisation, in Italy from 01Jan2010 to 31Dec2015

Brief summary: This is an independent, observational, retrospective post marketing study on the use of trabectedin in a clinical setting.

A data collection on the clinical use of the drug will help to improve knowledge and might contribute to optimize the clinical use of the drug.

Detailed description: This is a national, multi-centre observational retrospective and prospective chart review study of treatment patterns and clinical outcomes in a subset of patients with Soft Tissue Sarcoma who received trabectedin as per licensed indication.

In the absence of availability of existing databases, a retrospective chart review design was selected.

It is anticipated that the medical charts will contain the information required to answer study objectives. This chart review study will be conducted in 25 sites in Italy An estimated total of 900 charts will be abstracted. This study requires no intervention or interference with standard medical care, and thus it will not affect patient treatment.

The study is sponsored by Italian Sarcoma Group Charts of patients who initiated trabectedin as part of the approved treatment for a Soft Tissue Sarcoma , will be identified by site staff. Each identified chart will be assigned a unique study identification number. Site staff will review the medical charts for all identified patients to determine patient eligibility. Those patients who meet eligibility criteria will be enrolled into the final study cohort as subject.

Data from subject medical charts will be abstracted by local site study staff and entered at the site into an electronic data capture (EDC) system. The system will also facilitate the monitoring of the completeness and quality of study data as the study data accrue.

Eligibility criteria: Inclusion Criteria:

* Patients who received trabectedin according to the approved indication in the period January 2010 December 2015

Exclusion Criteria:

* Trabectedin started before January 2010 and after December 2015
* Participation into clinical trials with trabectedin
* Clinical chart missing, empty, or not retrievable.

Primary outcomes:
measure: Post-trabectedin received treatment
timeFrame: Through treatment completion, an average of 24 month
Secondary outcomes:
measure: Tumor response
timeFrame: after 6 months from trabectedin start date
measure: Trabectedin dose modification
timeFrame: Through treatment completion, an average of 24 month
measure: Progression-free survival
timeFrame: after 5 years and 3 years from trabectedin start date
measure: Trabectedin safety profile
timeFrame: Through treatment completion, an average of 24 month
measure: Overall survival
timeFrame: after 5 years and 3 years from trabectedin start date
Other outcomes:
measure: Histology related treatment response
timeFrame: after 6 months from trabectedin start date
Locations:
city: Alessandria
country: Italy
facility: A.O. SS Antonio e Biagio e Cesare Arrigo
state: AL
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II
state: BA
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
state: BG
city: Cagliari
country: Italy
facility: Ospedale Oncologico A. Businco
state: CA
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
state: FC
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: MI
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Paolo Giaccone
state: PA
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano
state: PD
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
state: PD
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Santa Chiara
state: PI
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
state: RM
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo
state: Torino
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi - Unit of Medical Oncology
city: Brescia (BS)
country: Italy
facility: Pres.Ospedal.Spedali Civili Brescia -
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Milano (MI)
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int)
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena - Policlinico
city: Napoli (NA)
country: Italy
facility: Irccs Istituto Nazionale Tumori Fondazione Pascale -
city: Prato
country: Italy
facility: Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4
city: Reggio EMilia
country: Italy
facility: Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario "Agostino Gemelli"
city: Rome
country: Italy
facility: Istituto Regina Elena - IFO
city: Torino (TO)
country: Italy
facility: Presidio Sanitario Gradenigo Di Torino
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Study officials:
affiliation: Italian Sarcoma Group
name: Stefano Ferrari, MD
role: PRINCIPAL_INVESTIGATOR
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