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Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma

NCT02247544 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-11-01

No results posted yet for this study

Summary

This is an Italian, multicentre, single arm, phase II study, with an intra-patient comparison end point. This study aims at confirming the activity of the drug trabectedin as second/further line treatment in retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma expressed in terms of slowing down tumour growth.

Another objective is to investigate this peculiar benefit of trabectedin in typical retroperitoneal sarcomas may be exploited to help multidisciplinary clinical decision-making in the management of retroperitoneal sarcomas

Conditions

  • Liposarcoma
  • Leiomyosarcoma

Interventions

DRUG

Trabectedin

Trabectedin administered at a dose of 1.5 mg/m2 - 1.3 mg/m2 (at investigator's discretion, with a top-dose of 2.6 total mg per cycle) as a 24-hour continuous infusion via a central venous access until progressive disease, major toxicity, patient's intolerance, unwillingness to continue treatment, or medical decision by the responsible physician

Sponsors & Collaborators

  • Istituto Di Ricerche Farmacologiche Mario Negri

    collaborator OTHER

  • Italian Sarcoma Group

    lead NETWORK

Principal Investigators

  • Paolo G. Casali, MD · IRCCS Fondazione Istituto Nazionale per la cura dei tumori di Milano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2019-03-12
Completion
2019-03-12

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02247544 on ClinicalTrials.gov