Retrospective Study of Trabectedin in Soft Tissue Sarcomas

NCT02793050 | Completed

• 1 other identifier: ISG TrObs
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 26

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.

Conditions

Sarcoma, Soft Tissue

Keywords

Trabectedin; Soft Tissue Sarcoma; Observational

Outcome Measures

Primary Outcomes (1)

• Post-trabectedin received treatment

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

  Through treatment completion, an average of 24 month

Secondary Outcomes (5)

• Tumor response

  after 6 months from trabectedin start date

• Trabectedin dose modification

  Through treatment completion, an average of 24 month

• Progression-free survival

  after 5 years and 3 years from trabectedin start date

• Trabectedin safety profile

  Through treatment completion, an average of 24 month

• Overall survival

  after 5 years and 3 years from trabectedin start date

Other Outcomes (1)

• Histology related treatment response

  after 6 months from trabectedin start date

Study Arms (1)

Trabectedin

Trabectedin give according the market authorization for advanced soft tissue sarcoma

Drug: Trabectedin

Interventions

Trabectedin DRUG

Collection of data on the clinical use of Trabectedin

Also known as: yondelis

Trabectedin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Italian Sarcoma Group: lead

Study Sites (26)

A.O. SS Antonio e Biagio e Cesare Arrigo

Alessandria, AL, 15100, Italy

Location

Istituto Tumori Giovanni Paolo II

Bari, BA, 70124, Italy

Location

Ospedali Riuniti di Bergamo

Bergamo, BG, Italy

Location

Ospedale Oncologico A. Businco

Cagliari, CA, 09122, Italy

Location

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

Meldola, FC, Italy

Location

Istituto Europeo di Oncologia

Milan, MI, 20141, Italy

Location

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

Location

Azienda Ospedaliera Universitaria Paolo Giaccone

Palermo, PA, 90127, Italy

Location

Centro di Riferimento Oncologico di Aviano

Aviano, PD, 33081, Italy

Location

Istituto Oncologico Veneto

Padua, PD, 35128, Italy

Location

Azienda Ospedaliera Universitaria Santa Chiara

Pisa, PI, 56124, Italy

Location

Policlinico Universitario Campus Biomedico

Roma, RM, 00128, Italy

Location

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Torino, 10060, Italy

Location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Policlinico S.Orsola Malpighi - Unit of Medical Oncology

Bologna, 40138, Italy

Location

Pres.Ospedal.Spedali Civili Brescia -

Brescia (BS), Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

Irccs Istituto Nazionale Dei Tumori (Int)

Milano (MI), 20133, Italy

Location

Azienda Ospedaliero-Universitaria di Modena - Policlinico

Modena, 41124, Italy

Location

Irccs Istituto Nazionale Tumori Fondazione Pascale -

Napoli (NA), Italy

Location

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

Prato, 59100, Italy

Location

Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia

Reggio Emilia, 42123, Italy

Location

Fondazione Policlinico Universitario "Agostino Gemelli"

Roma, 00168, Italy

Location

Istituto Regina Elena - IFO

Rome, 00100, Italy

Location

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

Torino, 10126, Italy

Location

Presidio Sanitario Gradenigo Di Torino

Torino (TO), Italy

Location

Related Publications (20)

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• 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.

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• 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.

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• 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.

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  PMID: 8873596 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 16721129 BACKGROUND

• 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.

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• 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.

  PMID: 16110008 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• Samuels BL, Chawla S, Patel S, von Mehren M, Hamm J, Kaiser PE, Schuetze S, Li J, Aymes A, Demetri GD. Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study. Ann Oncol. 2013 Jun;24(6):1703-9. doi: 10.1093/annonc/mds659. Epub 2013 Feb 5.

  PMID: 23385197 BACKGROUND

• Blay JY, Italiano A, Ray-Coquard I, Le Cesne A, Duffaud F, Rios M, Collard O, Bertucci F, Bompas E, Isambert N, Chaigneau L, Cassier P, Bui B, Decanter G, Derbel O, Coindre JM, Zintl P, Badri N, Penel N. Long-term outcome and effect of maintenance therapy in patients with advanced sarcoma treated with trabectedin: an analysis of 181 patients of the French ATU compassionate use program. BMC Cancer. 2013 Feb 6;13:64. doi: 10.1186/1471-2407-13-64.

  PMID: 23388156 BACKGROUND

• Le Cesne A, Blay JY, Domont J, Tresch-Bruneel E, Chevreau C, Bertucci F, Delcambre C, Saada-Bouzid E, Piperno-Neumann S, Bay JO, Mir O, Ray-Coquard I, Ryckewaert T, Valentin T, Isambert N, Italiano A, Clisant S, Penel N. Interruption versus continuation of trabectedin in patients with soft-tissue sarcoma (T-DIS): a randomised phase 2 trial. Lancet Oncol. 2015 Mar;16(3):312-9. doi: 10.1016/S1470-2045(15)70031-8. Epub 2015 Feb 11.

  PMID: 25680558 BACKGROUND

• Palmerini E, Sanfilippo R, Grignani G, Buonadonna A, Romanini A, Badalamenti G, Ferraresi V, Vincenzi B, Comandone A, Pizzolorusso A, Brunello A, Gelsomino F, De Pas T, Ibrahim T, Gurrieri L, Grosso F, Zanelli F, Pantaleo MA, Milesi L, Ciuffreda L, Ferrari V, Marchesi E, Quattrini I, Righi A, Setola E, Carretta E, Casali PG, Picci P, Ferrari S. Transcription regulators and ultra-rare and other rare translocation-related sarcomas treated with trabectedin: A proof of principle from a post-hoc analysis. Front Oncol. 2022 Dec 8;12:1042479. doi: 10.3389/fonc.2022.1042479. eCollection 2022.

  PMID: 36568164 DERIVED

• Palmerini E, Sanfilippo R, Grignani G, Buonadonna A, Romanini A, Badalamenti G, Ferraresi V, Vincenzi B, Comandone A, Pizzolorusso A, Brunello A, Gelsomino F, Pas T, Ibrahim T, Grosso F, Zanelli F, Pantaleo MA, Milesi L, Ciuffreda L, Ferrari V, Marchesi E, Quattrini I, Righi A, Setola E, Carretta E, Picci P, Ferrari S. Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Retrospective, Multicenter Study of the Italian Sarcoma Group. Cancers (Basel). 2021 Mar 2;13(5):1053. doi: 10.3390/cancers13051053.

  PMID: 33801399 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Stefano Ferrari, MD

  Italian Sarcoma Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 8, 2016
• Study Start: June 15, 2016
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (26)