Your browser doesn't support javascript.
loading
An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without bevacizumab in platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer patients previously treated with bevacizumab for front-line or platinum-sensitive ovarian cancer: rationale, design, and methods of the Japanese Gynecologic Oncology Group study JGOG3023.
Shoji, Tadahiro; Komiyama, Shinichi; Kigawa, Junzo; Tanabe, Hiroshi; Kato, Kazuyoshi; Itamochi, Hiroaki; Fujiwara, Hiroyuki; Kamiura, Shoji; Hamano, Tetsutaro; Sugiyama, Toru.
Afiliación
  • Shoji T; Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, Iwate, 020-8505, Japan. tshoji@iwate-med.ac.jp.
  • Komiyama S; Department of Gynecology, Toho University Ohashi Medical Center, Tokyo, Japan.
  • Kigawa J; Department of Obstetrics and Gynecology, Matsue City Hospital, Shimane, Japan.
  • Tanabe H; Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Kashiwa Hospital, Chiba, Japan.
  • Kato K; Department of Gynecology, Cancer Institute Hospital, Tokyo, Japan.
  • Itamochi H; Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, Iwate, 020-8505, Japan.
  • Fujiwara H; Department of Obstetrics and Gynecology, Jichi Medical University, Tochigi, Japan.
  • Kamiura S; Department of Gynecology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
  • Hamano T; Clinical Trial Coordinating Center, Kitasato Academic Research Organization, Kitasato University, Tokyo, Japan.
  • Sugiyama T; Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, Iwate, 020-8505, Japan.
BMC Cancer ; 18(1): 771, 2018 Jul 31.
Article en En | MEDLINE | ID: mdl-30064406
BACKGROUND: We present the study rationale and design of the JGOG3023 study, an open-label, parallel-arm, randomized, phase II trial that aimed to assess the efficacy and safety of chemotherapy with or without bevacizumab in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who were previously treated with bevacizumab for front-line or platinum-sensitive ovarian cancer. We hypothesize that patients treated with a combination of single-agent chemotherapy and bevacizumab will show improved progression-free survival (PFS) compared with those treated with single-agent chemotherapy alone, in the setting beyond disease progression following prior bevacizumab treatment. METHODS/DESIGN: A total of 106 patients who have recurrence or progression of ovarian cancer, while receiving chemotherapy or within 6 months after the final dose of platinum, after completing at least three cycles of bevacizumab plus platinum chemotherapy will be randomized in a 1:1 ratio to treatment with single-agent chemotherapy or single-agent chemotherapy combined with bevacizumab. For chemotherapy, one of the following four drugs will be chosen by an investigator: pegylated liposomal doxorubicin, topotecan, paclitaxel, or gemcitabine. The primary endpoint is investigator-assessed PFS. The secondary endpoints are overall survival, objective response rate, number of paracentesis, and response rate by CA125. Safety will be evaluated by the incidence of adverse events. DISCUSSION: This study will assess the efficacy and safety of bevacizumab in combination with single-agent chemotherapy, which could be used continuously after disease progression following standard platinum-based chemotherapy with bevacizumab. TRIAL REGISTRATION: UMIN000017247 (registered April 22, 2015).
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Neoplasias Peritoneales / Neoplasias de las Trompas Uterinas / Bevacizumab / Antineoplásicos Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Female / Humans Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2018 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Neoplasias Peritoneales / Neoplasias de las Trompas Uterinas / Bevacizumab / Antineoplásicos Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Female / Humans Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2018 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido