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Sarcoma, Soft TissueTrObsNCT02793050

Retrospective Study of Trabectedin in Soft Tissue Sarcomas

An observational study of Sarcoma, Soft Tissue, run by Italian Sarcoma Group at 26 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma, Soft Tissue
What is being tested?
Trabectedin
How many people
510 participants
Where
26 sitesItaly
Study dates
15 Jun 2016to 2 Oct 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with advanced soft tissue sarcoma who received trabectedin according its market authorisation, in Italy from 01Jan2010 to 31Dec2015

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Italy26 sites

  • A.O. SS Antonio e Biagio e Cesare Arrigo

    Alessandria, AL, 15100

  • Centro di Riferimento Oncologico di Aviano

    Aviano, PD, 33081

  • Istituto Tumori Giovanni Paolo II

    Bari, BA, 70124

  • Ospedali Riuniti di Bergamo

    Bergamo, BG

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

  • Policlinico S.Orsola Malpighi - Unit of Medical Oncology

    Bologna, 40138

  • Pres.Ospedal.Spedali Civili Brescia -

    Brescia (BS)

  • Ospedale Oncologico A. Businco

    Cagliari, CA, 09122

  • Fondazione del Piemonte per l'Oncologia IRCC Candiolo

    Candiolo, Torino, 10060

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST

    Meldola, FC

  • Istituto Europeo di Oncologia

    Milan, MI, 20141

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milano (MI), 20133

  • Azienda Ospedaliero-Universitaria di Modena - Policlinico

    Modena, 41124

  • Irccs Istituto Nazionale Tumori Fondazione Pascale -

    Napoli (NA)

  • Istituto Oncologico Veneto

    Padova, PD, 35128

  • Azienda Ospedaliera Universitaria Paolo Giaccone

    Palermo, PA, 90127

  • Azienda Ospedaliera Universitaria Santa Chiara

    Pisa, PI, 56124

  • Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4

    Prato, 59100

  • Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia

    Reggio Emilia, 42123

  • Policlinico Universitario Campus Biomedico

    Roma, RM, 00128

  • Fondazione Policlinico Universitario "Agostino Gemelli"

    Roma, 00168

  • Istituto Regina Elena - IFO

    Rome, 00100

  • Istituto Clinico Humanitas

    Rozzano, MI, 20089

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

    Torino, 10126

  • Presidio Sanitario Gradenigo Di Torino

    Torino (TO)

Other trials in Italy

About this study

Official title: Trabectedin in Soft Tissue Sarcomas. A Retrospective Observational Analysis (TrObs)

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.

Read the 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.

Being tested
Trabectedin
Keywords
Trabectedin, Soft Tissue Sarcoma, Observational
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrabectedinDrug

    Also called yondelis

    Collection of data on the clinical use of Trabectedin

Study groups in NCT02793050
Study groupRoleWhat they receive
TrabectedinTrabectedin give according the market authorization for advanced soft tissue sarcoma
Receives: Drug: Trabectedin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-trabectedin received treatment

    Number of chemotherapy lines received after trabectedin given according to the approved indication

    Measured: Through treatment completion, an average of 24 month

Secondary outcomes (5)

  1. Tumor response

    Percent of patients with non progressing disease at 6 months

    Measured: after 6 months from trabectedin start date

  2. Trabectedin dose modification

    Describe trabectedin treatment experience in term of dose for patients with Soft Tissue Sarcoma treated with trabectedin as per market indication

    Measured: Through treatment completion, an average of 24 month

  3. Progression-free survival

    Describe progression-free survival (PFS) for patients with Soft Tissue Sarcoma who received trabectedin.

    Measured: after 5 years and 3 years from trabectedin start date

  4. Trabectedin safety profile

    Describe trabectedin safety profile in terms of number of participants with treatment-related adverse events as assessed by CTCAE v4.0 tha caused treatment discontinuation

    Measured: Through treatment completion, an average of 24 month

  5. Overall survival

    Describe overall survival (OS) for patients with Soft Tissue Sarcoma who received trabectedin.

    Measured: after 5 years and 3 years from trabectedin start date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2016 (estimated)
  2. Study start15 Jun 2016
  3. Primary completion2 Oct 2018
  4. Study completion2 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02793050
Sponsor's protocol ID
ISG TrObs
Acronym
TrObs
Status last verified
May 2019
First submitted
25 May 2016
Last updated
10 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Aggregate anonymized results will be available upon request at the end of the study

Publications

  • Stiller CA, Trama A, Brewster DH, Verne J, Bouchardy C, Navarro C, Chirlaque MD, Marcos-Gragera R, Visser O, Serraino D, Weiderpass E, Dei Tos AP, Ascoli V; RARECARE Working Group. Descriptive epidemiology of Kaposi sarcoma in Europe. Report from the RARECARE project. Cancer Epidemiol. 2014 Dec;38(6):670-8. doi: 10.1016/j.canep.2014.09.009. Epub 2014 Oct 22.

    PubMed 25454979

  • ESMO/European Sarcoma Network Working Group. Soft tissue and visceral sarcomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014 Sep;25 Suppl 3:iii102-12. doi: 10.1093/annonc/mdu254. No abstract available.

    PubMed 25210080

  • Judson I, Verweij J, Gelderblom H, Hartmann JT, Schoffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litiere S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. doi: 10.1016/S1470-2045(14)70063-4. Epub 2014 Mar 5.

    PubMed 24618336

  • Sleijfer S, Ouali M, van Glabbeke M, Krarup-Hansen A, Rodenhuis S, Le Cesne A, Hogendoorn PC, Verweij J, Blay JY. Prognostic and predictive factors for outcome to first-line ifosfamide-containing chemotherapy for adult patients with advanced soft tissue sarcomas: an exploratory, retrospective analysis on large series from the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group (EORTC-STBSG). Eur J Cancer. 2010 Jan;46(1):72-83. doi: 10.1016/j.ejca.2009.09.022.

    PubMed 19853437

  • Italiano A, Mathoulin-Pelissier S, Cesne AL, Terrier P, Bonvalot S, Collin F, Michels JJ, Blay JY, Coindre JM, Bui B. Trends in survival for patients with metastatic soft-tissue sarcoma. Cancer. 2011 Mar 1;117(5):1049-54. doi: 10.1002/cncr.25538. Epub 2010 Oct 13.

    PubMed 20945333

  • Pommier Y, Kohlhagen G, Bailly C, Waring M, Mazumder A, Kohn KW. DNA sequence- and structure-selective alkylation of guanine N2 in the DNA minor groove by ecteinascidin 743, a potent antitumor compound from the Caribbean tunicate Ecteinascidia turbinata. Biochemistry. 1996 Oct 15;35(41):13303-9. doi: 10.1021/bi960306b.

    PubMed 8873596

  • Bonfanti M, La Valle E, Fernandez Sousa Faro JM, Faircloth G, Caretti G, Mantovani R, D'Incalci M. Effect of ecteinascidin-743 on the interaction between DNA binding proteins and DNA. Anticancer Drug Des. 1999 Jun;14(3):179-86.

    PubMed 10500494

  • Erba E, Bergamaschi D, Bassano L, Damia G, Ronzoni S, Faircloth GT, D'Incalci M. Ecteinascidin-743 (ET-743), a natural marine compound, with a unique mechanism of action. Eur J Cancer. 2001 Jan;37(1):97-105. doi: 10.1016/s0959-8049(00)00357-9.

    PubMed 11165136

  • Fayette J, Coquard IR, Alberti L, Boyle H, Meeus P, Decouvelaere AV, Thiesse P, Sunyach MP, Ranchere D, Blay JY. ET-743: a novel agent with activity in soft-tissue sarcomas. Curr Opin Oncol. 2006 Jul;18(4):347-53. doi: 10.1097/01.cco.0000228740.70379.3f.

    PubMed 16721129

  • D'Incalci M, Badri N, Galmarini CM, Allavena P. Trabectedin, a drug acting on both cancer cells and the tumour microenvironment. Br J Cancer. 2014 Aug 12;111(4):646-50. doi: 10.1038/bjc.2014.149. Epub 2014 Apr 22.

    PubMed 24755886

  • Garcia-Carbonero R, Supko JG, Maki RG, Manola J, Ryan DP, Harmon D, Puchalski TA, Goss G, Seiden MV, Waxman A, Quigley MT, Lopez T, Sancho MA, Jimeno J, Guzman C, Demetri GD. Ecteinascidin-743 (ET-743) for chemotherapy-naive patients with advanced soft tissue sarcomas: multicenter phase II and pharmacokinetic study. J Clin Oncol. 2005 Aug 20;23(24):5484-92. doi: 10.1200/JCO.2005.05.028.

    PubMed 16110008

  • Garcia-Carbonero R, Supko JG, Manola J, Seiden MV, Harmon D, Ryan DP, Quigley MT, Merriam P, Canniff J, Goss G, Matulonis U, Maki RG, Lopez T, Puchalski TA, Sancho MA, Gomez J, Guzman C, Jimeno J, Demetri GD. Phase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive sarcomas of soft tissues refractory to chemotherapy. J Clin Oncol. 2004 Apr 15;22(8):1480-90. doi: 10.1200/JCO.2004.02.098.

    PubMed 15084621

  • Le Cesne A, Ray-Coquard I, Duffaud F, Chevreau C, Penel N, Bui Nguyen B, Piperno-Neumann S, Delcambre C, Rios M, Chaigneau L, Le Maignan C, Guillemet C, Bertucci F, Bompas E, Linassier C, Olivier T, Kurtz JE, Even C, Cousin P, Yves Blay J; French Sarcoma Group. Trabectedin in patients with advanced soft tissue sarcoma: a retrospective national analysis of the French Sarcoma Group. Eur J Cancer. 2015 Apr;51(6):742-50. doi: 10.1016/j.ejca.2015.01.006. Epub 2015 Feb 23.

    PubMed 25727882

  • Demetri GD, Chawla SP, von Mehren M, Ritch P, Baker LH, Blay JY, Hande KR, Keohan ML, Samuels BL, Schuetze S, Lebedinsky C, Elsayed YA, Izquierdo MA, Gomez J, Park YC, Le Cesne A. Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. J Clin Oncol. 2009 Sep 1;27(25):4188-96. doi: 10.1200/JCO.2008.21.0088. Epub 2009 Aug 3.

    PubMed 19652065

  • Grosso F, Sanfilippo R, Virdis E, Piovesan C, Collini P, Dileo P, Morosi C, Tercero JC, Jimeno J, D'Incalci M, Gronchi A, Pilotti S, Casali PG. Trabectedin in myxoid liposarcomas (MLS): a long-term analysis of a single-institution series. Ann Oncol. 2009 Aug;20(8):1439-44. doi: 10.1093/annonc/mdp004. Epub 2009 May 22.

    PubMed 19465423

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcoma, Soft Tissue, run by Italian Sarcoma Group at 26 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-trabectedin received treatment (time frame: Through treatment completion, an average of 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02793050, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.

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