Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

Sponsor
Italian Sarcoma Group
Study ID
NCT04383119
Phase
PHASE2
Status
Recruiting
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Conditions

  • Leiomyosarcoma of Ovary
  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trabectedin — DRUG
    Trabectedin in monotherapy
  • Gemcitabine — DRUG
    Gemcitabine, control arm
  • No Intervention: Observational Cohort — DRUG
    Treatment according clinical practice

Study Details

Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator. In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option. In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype.

Key Dates

First listed
May 12, 2020
Start date
Oct 29, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Trabectedin at the dose of 1.5 mg/m2-1.3 mg/m2 with a top-dose of 2.6 total mg per cycle (according the clinical practice in pretreated patients and in all our ISG studies) will be administered via a central venous catheter as a 24-hour infusion on day 1 of 21-days treatment cycles
  • Active Comparator: Arm B
    Gemcitabine 800-1000 mg/m2 will be administered via a central venous catheter on days 1,8 every 21 days
  • Active Comparator: Observational Cohort
    Treatmen according clinical practice (not defined in advance). The patient who will refuse randomization between Arm A and B can choose to participate to the observational cohort to the study, where they will be treated according clinical practice

Primary Outcome Measure

Compare the Growth Modulation Index (GMI) in patients treated with Trabectedin or Gemcitabine in second line [ Time Frame: Week 6, week 12, week 18, week 27, week 36 and week 45 ]

Central Contacts

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