IRCI Gynae Sarcomas, High Grade Uterine Sarcoma

NCT ID: NCT01979393

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-02
• Study Completion Date: 2024-01-15

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cabozantinib

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Cabozantinib

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Cabozantinib

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynecologic Oncology Group

NETWORK

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle Ray-Coquard, MD

Role: STUDY_CHAIR

Centre Léon Bérard, Lyon, France

Nicholas Reed, MD

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital , Glasgow, United Kingdom

Locations

Institut Bergonie

Bordeaux, , France

Institut Bergonie

Bordeaux, , France

Centre Leon Berard

Lyon, , France

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

Nantes, , France

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, , Netherlands

Hospital General Vall D'Hebron

Barcelona, , Spain

Hospital Universitario San Carlos

Madrid, , Spain

Cambridge University Hospital NHS - Addenbrookes Hospital

Cambridge, , United Kingdom

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

Glasgow, , United Kingdom

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

Leeds, , United Kingdom

Royal Marsden Hospital

London, , United Kingdom

University College London Hospitals NHS Foundation Trust - University College Hospital

London, , United Kingdom

Nottingham University Hospitals NHS Trust - City Hospital

Nottingham, , United Kingdom

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford, , United Kingdom

Countries

France; Italy; Netherlands; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34009140 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32546554 (View on PubMed)

Other Identifiers

2013-000762-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UC1306

Identifier Type: OTHER

Identifier Source: secondary_id

EORTC-62113-55115

Identifier Type: -

Identifier Source: org_study_id