Journal of Korean medical science · 2022
Mother-Adolescent Discrepancies in Reporting Sleep Disturbances: Effects of Diagnosis and Mother's Occupation.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Wei Shuhua, Li Xiaofan, Liu Zi, Wei Lichun, Zou Lijuan, Zhang Yunyan, Sun Xiaoge, Gao Yuhua, Zhuo Yanhong, Zhang Min, Qu Ang, Zhang Hua, Guo Hongyan, Jiang Ping, Wang Junjie
Аннотация
BACKGROUND: The current standard for treating locally advanced cervical cancer is cisplatin-based concurrent chemoradiotherapy (CCRT). Overexpression of the epidermal growth factor receptor (EGFR) has been linked to reduced responsiveness to CCRT and poorer outcomes. Therefore, targeting EGFR represents a promising therapeutic approach in cervical cancer. The purpose of this study is to evaluate the efficacy and safety of nimotuzumab concurrent with and following CCRT vs. CCRT alone in patients with locally advanced cervical squamous carcinoma. Adding nimotuzumab to CCRT will enhance progression-free survival (PFS) in patients with International Federation of Gynecology and Obstetrics (FIGO) 2018 stages IB3 to IVA cervical squamous carcinoma, compared to CCRT alone.
METHODS: The NOTABLE-306 trial comprises a phase Ib dose-escalation stage (3+3 design) to determine the optimal nimotuzumab dose, followed by a phase III randomized, multicenter, double-blind, placebo-controlled stage. Patients will be randomized 1:1 to receive weekly nimotuzumab or placebo for 8 cycles, followed by biweekly maintenance for 24 weeks. All participants will undergo external beam radiotherapy (EBRT, 45-50 Gy in 25 fractions) with cisplatin (40 mg/m², weekly) for 5 weeks, followed by image-guided brachytherapy. Eligible patients are treatment-naïve females aged 18-80 with histologically confirmed cervical squamous carcinoma (FIGO 2018 stages IB3-IVA) and no prior definitive treatments. The primary endpoints include dose-limiting toxicity in phase Ib and PFS in phase III, which were assessed by an independent review using Response Evaluation Criteria in Solid Tumors v1.1 criteria. Stage I includes up to 26 patients to determine dosing. Stage II will enroll approximately 460 patients randomized 1:1 to receive either nimotuzumab or placebo with and following CCRT. Patient enrollment was started in April 2024 with an estimated completion date of April 2030.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06333821.
METHODS: The NOTABLE-306 trial comprises a phase Ib dose-escalation stage (3+3 design) to determine the optimal nimotuzumab dose, followed by a phase III randomized, multicenter, double-blind, placebo-controlled stage. Patients will be randomized 1:1 to receive weekly nimotuzumab or placebo for 8 cycles, followed by biweekly maintenance for 24 weeks. All participants will undergo external beam radiotherapy (EBRT, 45-50 Gy in 25 fractions) with cisplatin (40 mg/m², weekly) for 5 weeks, followed by image-guided brachytherapy. Eligible patients are treatment-naïve females aged 18-80 with histologically confirmed cervical squamous carcinoma (FIGO 2018 stages IB3-IVA) and no prior definitive treatments. The primary endpoints include dose-limiting toxicity in phase Ib and PFS in phase III, which were assessed by an independent review using Response Evaluation Criteria in Solid Tumors v1.1 criteria. Stage I includes up to 26 patients to determine dosing. Stage II will enroll approximately 460 patients randomized 1:1 to receive either nimotuzumab or placebo with and following CCRT. Patient enrollment was started in April 2024 with an estimated completion date of April 2030.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06333821.