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Trabectedin First Line Therapy In Unfit Sarcoma Study

NCT02066675 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-04-11

No results posted yet for this study

Summary

Phase II, non-randomized, two-stage study according to Bryant \& Day The study enroll patients with Metastatic and locally advanced soft tissue sarcoma unfit to receive standard chemotherapy (doxorubicin/epirubicin and/or ifosfamide)

Conditions

  • Metastatic and Locally Advanced Soft Tissue Tumor Patients Unfit to Receive
  • Standard Chemotherapy

Interventions

DRUG

Trabectedin

Each patients will receive intravenous trabectedin (1.5 mg/mq-1.3 mg/mq) over 24 hours every 3 weeks

Sponsors & Collaborators

  • Italian Sarcoma Group

    lead NETWORK

Principal Investigators

  • Federica Grosso, MD · ASO SS Antonio e Biagio e C Arrigo Alessandria, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-12-31
Completion
2016-12-31

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 NCT02066675 on ClinicalTrials.gov