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Comparing biweekly single-dose actinomycin D with multiday methotrexate therapy for low-risk gestational trophoblastic neoplasia (FIGO Score 0-4): study protocol for a prospective, multicentre, randomized trial.
Jiang, Fang; Mao, Ming-Yi; Xiang, Yang; Lu, Xin; Guan, Chong-Li; Jiao, Lan-Zhou; Wan, Xi-Run; Feng, Feng-Zhi; Ren, Tong; Yang, Jun-Jun; Zhao, Jun.
Afiliación
  • Jiang F; Department of Obstetrics & Gynaecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, National Clinical Research Center for Obstetric & Gynaecologic Diseases, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
  • Mao MY; Department of Obstetrics & Gynaecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, National Clinical Research Center for Obstetric & Gynaecologic Diseases, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
  • Xiang Y; Department of Obstetrics & Gynaecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, National Clinical Research Center for Obstetric & Gynaecologic Diseases, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China. X
  • Lu X; Department of Gynecology Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.
  • Guan CL; Department of Gynecology Oncology, Gansu Provincial Maternity and Child-Care Hospital, Lanzhou, Gansu Province, China.
  • Jiao LZ; Department of Gynecology Oncology, Dalian Women's and Children's Medical Center (Group), No.1 Dunhuang Road Shahekou, Dalian, Liaoning, China.
  • Wan XR; Department of Gynecology Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.
  • Feng FZ; Department of Obstetrics & Gynaecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, National Clinical Research Center for Obstetric & Gynaecologic Diseases, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
  • Ren T; Department of Obstetrics & Gynaecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, National Clinical Research Center for Obstetric & Gynaecologic Diseases, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
  • Yang JJ; Department of Obstetrics & Gynaecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, National Clinical Research Center for Obstetric & Gynaecologic Diseases, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
  • Zhao J; Department of Obstetrics & Gynaecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, National Clinical Research Center for Obstetric & Gynaecologic Diseases, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
BMC Cancer ; 23(1): 784, 2023 Aug 23.
Article en En | MEDLINE | ID: mdl-37612621
ABSTRACT

BACKGROUND:

Single-agent chemotherapy using methotrexate or actinomycin D is the first-line treatment for patients with low-risk gestational trophoblastic neoplasia. Various methotrexate-based and actinomycin D-based single-agent regimens can be used. However, there is insufficient evidence to determine the superior regimen. To guide doctors in selecting a single-agent chemotherapy regimen for patients with low-risk gestational trophoblastic neoplasia, we will compare two regimens.

METHODS:

We will conduct a multicentre, randomized, prospective clinical trial. Selected low-risk gestational trophoblastic neoplasia patients (FIGO score 0-4) will be randomized 11 to a biweekly single-dose actinomycin D group or a multiday methotrexate therapy group. The actinomycin D group will receive IV pulse actinomycin D (1.25 mg/m2) every 14 days, and the methotrexate group will receive methotrexate (50 mg) intramuscularly on days 1, 3, 5, and 7 (4 doses per cycle) and leucovorin (15 mg) intramuscularly on days 2, 4, 6, and 8. This process will be repeated every 14 days. The primary endpoints will include the complete remission rate by single-agent therapy and the overall complete remission rate. The secondary endpoints will include the duration needed to achieve complete remission after single-agent chemotherapy, number of courses needed to achieve complete remission after single-agent chemotherapy, incidence and severity of adverse effects, effects on menstrual conditions and ovarian function based on the anti-Mullerian hormone level, and patient-reported quality of life.

DISCUSSION:

Previous clinical trials comparing biweekly single-dose actinomycin D with multiday methotrexate therapy for treating low-risk gestational trophoblastic neoplasia patients failed to meet the expected case number. Through this multicentre study, the complete remission ratio and efficacy difference between biweekly single-dose actinomycin D and multiday methotrexate therapy will be obtained. This study will also provide the basis for formulating a preferred regimen for treating patients with low-risk gestational trophoblastic neoplasia. TRIAL REGISTRATION ClinicalTrials.gov NCT04562558, Registered on 13 September 2020 (Protocol version 2020-9-24, version 1.0).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Metotrexato / Enfermedad Trofoblástica Gestacional Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Qualitative_research / Risk_factors_studies Aspecto: Patient_preference Límite: Female / Humans / Pregnancy Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: China

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Metotrexato / Enfermedad Trofoblástica Gestacional Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Qualitative_research / Risk_factors_studies Aspecto: Patient_preference Límite: Female / Humans / Pregnancy Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: China
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