Abstract | INTRODUCTION: METHODS AND ANALYSIS: Eligible patients with histologically confirmed cervical cancer stage IIA2 to IVA of the International Federation of Gynaecology and Obstetrics, adequate organ function and no locoregional disease or distant metastasis after completion of primary treatment will be screened for HPV DNA in exfoliated cell at 1 month post-RT. Patients with undetectable HPV DNA will undergo standard surveillance. Patients with detectable HPV DNA will be randomly assigned to either adjuvant chemotherapy with docetaxel and nedaplatin for four cycles (arm 1) or observation (arm 2). Patients will be stratified for primary treatment (RT vs CRT). The primary endpoint is relapse-free survival. ETHICS AND DISSEMINATION: This protocol received a favourable ethical opinion from the Ethics Committee of the Second Affiliated Hospital of Fujian Medical University on 6 February, 2018, (No. 28). The trial results will be published in peer-reviewed journals and presented in conferences. A summary of the findings will be made available to participants. TRIAL REGISTRATION NUMBER: ChiCTR-IIR-17012655; Pre-results.
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Authors | Yanhong Wang, Yi Ouyang, Jingjing Su, Jing Liu, Qunrong Cai, Qin Xu, Zhigang Bai, Xinping Cao |
Journal | BMJ open
(BMJ Open)
Vol. 9
Issue 10
Pg. e028171
(10 07 2019)
ISSN: 2044-6055 [Electronic] England |
PMID | 31594870
(Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
Chemical References |
- Antineoplastic Agents
- DNA, Viral
- Organoplatinum Compounds
- Docetaxel
- nedaplatin
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Topics |
- Adult
- Antineoplastic Agents
(administration & dosage)
- Chemotherapy, Adjuvant
(methods)
- DNA, Viral
(isolation & purification)
- Disease-Free Survival
- Docetaxel
(administration & dosage)
- Female
- Humans
- Multicenter Studies as Topic
- Neoplasm Recurrence, Local
(epidemiology)
- Neoplasm Staging
- Organoplatinum Compounds
(administration & dosage)
- Papillomaviridae
(genetics)
- Radiotherapy
(methods)
- Randomized Controlled Trials as Topic
- Uterine Cervical Neoplasms
(pathology, therapy, virology)
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