IRCI Gynae Sarcomas, High Grade Uterine Sarcoma

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT01979393
Phase
PHASE2
Status
Completed

Conditions

  • Uterine Sarcoma

Eligibility Criteria

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

Interventions

Study Details

This study aims to investigate a drug called Cabozantinib which belongs to a family of drugs that have effects on tumour growth, blood supply, invasion and spread. Therefore, we want to find out whether taking cabozantinib after treatment with surgery and chemotherapy is effective and safe for patients who responded or had stable disease after their chemotherapy. All participants will receive 4-6 cycles of standard chemotherapy. Those with stabilization or response to the standard chemotherapy will be split into 2 groups (cabozantinib or placebo).

Key Dates

Start date
Feb 2, 2015
Status verified
Jul 2025
Primary completion
May 18, 2022
Completion
Jan 15, 2024

Study Design

Enrollment
58 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib
    Cabozantinib maintenance 60 mg daily for 2 years or until withdrawal criterion After documented disease progression (according to RECIST 1.1), the treatment will be unblinded. Subjects receiving cabozantinib shall be further treated at the investigator discretion.
  • Experimental: Placebo
    Placebo daily for 2 years or until withdrawal criterion. After documented disease progression (according to RECIST 1.1), the treatment will be unblinded. Subjects receiving placebo shall be offered the option of receiving cabozantinib up to further progression. This is not mandatory and treatment is at the investigator decision.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 3.5 years from first patient in ]

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