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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).
Ray-Coquard, Isabelle; Hatcher, Helen; Bompas, Emmanuelle; Casado, Antonio; Westermann, Annekke; Isambert, Nicolas; Casali, Paolo Giovanni; Pratap, Sarah; Stark, Daniel; Valverde, Claudia; Anand, Anjana; Huizing, Manon; Floquet, Anne; Lindner, Lars; Hermes, Barbara; Seddon, Beatrice; Coens, Corneel; Jones, Robin; Reed, Nick.
Afiliação
  • Ray-Coquard I; Centre Leon Berard, Lyon, Rhône-Alpes, France isabelle.ray-coquard@lyon.unicancer.fr.
  • Hatcher H; Oncology, Université Claude Bernard Lyon 1, Villeurbanne, Auvergne-Rhône-Alpes, France.
  • Bompas E; medical oncology, Cambridge University, Cambridge, Cambridgeshire, UK.
  • Casado A; Medical Oncology Department, ICO, Saint Herblain, Pays de la Loire, France.
  • Westermann A; Medical Oncology Department, Complutense University of Madrid, Madrid, Comunidad de Madrid, Spain.
  • Isambert N; Medical Oncology Department, Academisch Medisch Centrum, Amsterdam, North Holland, The Netherlands.
  • Casali PG; Medical Oncology Department, Centre Georges-François Leclerc, Dijon, Bourgogne-Franche-Comté, France.
  • Pratap S; Medical Oncology Department, IRCCS, Milano, Lombardia, Italy.
  • Stark D; Medical Oncology Department, Oxford University, Oxford, Oxfordshire, UK.
  • Valverde C; Medical Oncology Department, Leeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK.
  • Anand A; Medical Oncology Department, Vall d'Hebron Hospital, Barcelona, Catalunya, Spain.
  • Huizing M; Medical Oncology Department, Nottingham Trent University, Nottingham, Nottinghamshire, UK.
  • Floquet A; Medical Oncology Department, Universitair Ziekenhuis Antwerpen, Edegem, Antwerp, Belgium.
  • Lindner L; Medical Oncology Department, Institut Bergonié, Bordeaux, Aquitaine, France.
  • Hermes B; Medical Oncology Department, Ludwig-Maximilians-Universitat Munchen, Munchen, Bayern, Germany.
  • Seddon B; Medical Oncology Department, Eberhard Karls Universitat Tubingen, Tubingen, Baden-Württemberg, Germany.
  • Coens C; Medical Oncology Department, University College London, London, London, UK.
  • Jones R; Statistics and Quality of Life, EORTC, Brussels, Belgium.
  • Reed N; Medical Oncology, Royal Marsden Hospital NHS Trust, London, London, UK.
Int J Gynecol Cancer ; 30(10): 1633-1637, 2020 10.
Article em En | MEDLINE | ID: mdl-32546554
BACKGROUND: Uterine sarcomas are a group of rare tumors that include different subtypes. Patients with histopathological high-grade diseases are at high-risk of recurrence or progression, and have a poor prognosis. We aim to explore the most appropriate management in patients with uterine high-grade sarcomas. PRIMARY OBJECTIVE: To assess the efficacy of maintenance treatment with cabozantinib in patients with high-grade uterine sarcomas who achieved clinical benefit after standard chemotherapy. STUDY HYPOTHESIS: Maintenance treatment with cabozantinib after standard chemotherapy given as an adjuvant treatment after curative surgery, or in locally advanced or metastatic disease, increases progression-free survival compared with placebo TRIAL DESIGN: This is a randomized double blinded phase II trial. MAJOR INCLUSION/EXCLUSION CRITERIA: The study is enrolling adult patients with high-grade undifferentiated uterine sarcomas, high-grade endometrial stromal sarcomas, high-grade leiomyosarcoma, and high-grade adenosarcoma, FIGO (Federation International gynecologue Obstétricien) stage II/III to IV in stable disease or who achieved complete or partial response with doxorubicin ± ifosfamide, who are assigned 1:1 to 60 mg daily cabozantinib (experimental arm) or placebo (control arm), as maintenance therapy. Exclusion criteria include low-grade sarcoma. PRIMARY ENDPOINT: Progression-free survival at 4 months. SAMPLE SIZE: The study plans to enroll 90 patients to allow the randomization of 54 patients to detect an improvement in 4-month progression-free survival from 50% to 80% with 15% significance level and 85% power. Estimated dates for accrual completion: recruitment for the trial started in February 2015, and has currently enrolled 83 patients, of whom 35 patients have been randomized. The end of recruitment is anticipated for December 2020. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, number NCT01979393.
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Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Piridinas / Neoplasias Uterinas / Sarcoma do Estroma Endometrial / Anilidas Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Female / Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Piridinas / Neoplasias Uterinas / Sarcoma do Estroma Endometrial / Anilidas Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Female / Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article