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Uterine SarcomaPhase 2NCT01979393

IRCI Gynae Sarcomas, High Grade Uterine Sarcoma

A Phase 2 study testing Cabozantinib in people with Uterine Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Sarcoma
What is being tested?
Cabozantinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
15 sitesin 5 countries
Study dates
2 Feb 2015to 15 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who are suitable for treatment with doxorubicin +/- ifosfamide and fall within one of the following patient populations:
  • HGUS, HGESS, HGLMS and HG adenosarcoma
  • FIGO stage II and stage III : if adjuvant chemotherapy is proposed
  • FIGO stage IV: if first line chemotherapy is proposed
  • Metastatic: diagnosed with disease relapse after local treatment for primary tumor
  • at least 18 years old
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  • written informed consent
  • Central pathological confirmation: Histological evidence of HGUS, HGESS, HGLMS and HG adenosarcoma
  • Non-progressive patients (CR, PR, SD) at the end of the first line treatment (standard chemotherapy consisting of 4 to 6 cycles of anthracyclines alone or in combination with ifosfamide)
  • WHO/ECOG performance status 0-2
  • Adequate organ and bone marrow function within 3 days prior to the first dose of study treatment (Cabozantinib/placebo)
  • Clinically normal cardiac function
  • Women of child bearing potential must have a negative serum/urine pregnancy test within 3 days prior to the first dose of study treatment
  • Adequate birth control measures

Who cannot join

  • low-grade ESS, leiomyosarcoma (low or intermediate), carcinosarcoma, low-grade adenosarcoma, rhabdomyosarcoma (alveolar or embryonal) and soft tissue PNET of uterus/cervix.
  • contraindications to cabozantinib
  • not able to swallow and retain oral tablets
  • planned use of chemotherapy, radiation therapy, radionuclide treatment, small molecule tyrosine kinase inhibitor or hormonal therapy, and any other investigational agent (Cabozantinib/placebo) during the treatment period
  • concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
  • patient with poorly controlled hypertension defined at baseline as blood pressure >150/90
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  • patients who have suffered a cerebrovascular accident at any time in the past, patients who have suffered a transient ischemic attack in the past 6 months, patients who have suffered a deep venous thrombosis (DVT) or a pulmonary embolism in the past 6 months
  • Gastrointestinal disorders
  • patients with radiographic evidence of cavitating pulmonary lesion(s)
  • patients with tumor in contact with, invading or encasing any major blood vessels
  • patients evidence of tumor invading the GI tract
  • evidence of active bleeding or bleeding diathesis
  • hemoptysis ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment
  • signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
  • clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment
  • prior major surgery or trauma within 6 weeks prior to first dose of study drug and any wound, fracture, or ulcer should be completely healed
  • concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5

Trial locations and contacts

15 sites in 5 countries.

15 sites in 5 countries

United Kingdom7 sites

  • Cambridge University Hospital NHS - Addenbrookes Hospital

    Cambridge

  • NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

    Glasgow

  • Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

    Leeds

  • Royal Marsden Hospital

    London

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham

  • Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford

Other trials in United Kingdom

France4 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Institut Bergonie

    Bordeaux

  • Centre Leon Berard

    Lyon, 69373

  • Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

    Nantes

Other trials in France

Spain2 sites

  • Hospital General Vall D'Hebron

    Barcelona, 08035

  • Hospital Universitario San Carlos

    Madrid, 28040

Other trials in Spain

Italy1 site

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

Other trials in Italy

Netherlands1 site

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

Official title: A Randomized Double-blind Phase II Study Evaluating the Role of Maintenance Therapy With Cabozantinib in High Grade Uterine Sarcoma (HGUtS) After Stabilization or Response to Doxorubicin +/- Ifosfamide Following Surgery or in Metastatic First Line Treatment

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).

Conditions
Uterine Sarcoma
Being tested
Cabozantinib, Placebo
Keywords
Locally advanced, stage III, stage IV, residual disease after primary surgery, newly diagnosed HGUS, Metastatic
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01979393
Study groupRoleWhat they receive
CabozantinibExperimentalCabozantinib 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.
Receives: Drug: Cabozantinib
PlaceboExperimentalPlacebo 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.
Receives: Drug: Cabozantinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    The primary endpoint is PFS rate at 4 months after randomization to cabozantinib or placebo

    Measured: 3.5 years from first patient in

Secondary outcomes (7)

  1. Progression free survival

    Measured: 3.5 years from first patient in

  2. Overall survival

    Measured: 3.5 years from first patient in

  3. Response rate

    Measured: 3.5 years from first patient in

  4. Duration of response to cabozantinib

    Measured: 3.5 years from first patient in

  5. Response rate to anthracycline-based chemotherapy for the patients with measurable disease

    Measured: 3.5 years from first patient in

  6. Assessment of global health status/QoL scale

    The primary health-related quality of life endpoint that is considered of interest for this study is the global health status/QoL scale

    Measured: 3.5 years from first patient in

  7. Occurence of Adverse Events

    This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.

    Measured: 3.5 years from first patient in

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2013 (estimated)
  2. Study start2 Feb 2015
  3. Primary completion18 May 2022
  4. Study completion15 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01979393
Sponsor's protocol ID
EORTC-62113-55115
Other IDs
2013-000762-11, UC1306
Status last verified
Jul 2025
First submitted
4 Nov 2013
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Hanvic B, Ray-Coquard I. Gynecological sarcomas: literature review of 2020. Curr Opin Oncol. 2021 Jul 1;33(4):345-350. doi: 10.1097/CCO.0000000000000753.

    PubMed 34009140

  • Ray-Coquard I, Hatcher H, Bompas E, Casado A, Westermann A, Isambert N, Casali PG, Pratap S, Stark D, Valverde C, Anand A, Huizing M, Floquet A, Lindner L, Hermes B, Seddon B, Coens C, Jones R, Reed N. A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in high-grade uterine sarcoma after stabilization or response to doxorubicin +/- ifosfamide following surgery or in metastatic first line treatment (EORTC62113). Int J Gynecol Cancer. 2020 Oct;30(10):1633-1637. doi: 10.1136/ijgc-2020-001519. Epub 2020 Jun 15.

    PubMed 32546554

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabozantinib in people with Uterine Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United Kingdom, France, Spain, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 3.5 years from first patient in). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01979393, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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