A Multicenter, Non-inferiority, Phase 3, Randomized Controlled Study of Moderated Hypofractionated Online Adaptive Radiotherapy for Cervical Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The most common external beam radiotherapy fractionation scheme for cervical cancer is 45-50.4 Gy delivered in 25-28 fractions. However, prolonged treatment duration can lead to insufficient availability of medical resources. We hope to assess the safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with brachytherapy in patients with cervical cancer in a multicenter study.
详细描述
This is a multicenter, non-inferiority, phase 3, randomized controlled study. This study investigates the role of moderated hypofractionated online adaptive radiotherapy by randomizing patients to this experimental regimen versus the standard of treatment.The purpose of this study is to access safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with high-dose-rate brachytherapy in patients with cervical cancer, which based on the previous research (NCT05994300).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient is fully voluntary and has the capacity for autonomy, signing the informed consent form 30 days prior to enrollment
- •Age ≥18 and ≤75 years
- •FIGO stage IB-IIIB cervical cancer; IIIC1 (lymph node metastasis ≤2 cm, without common iliac lymph node metastasis)
- •Pathologically diagnosed as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- •Concurrent weekly cisplatin therapy ± immunotherapy
- •Able to undergo brachytherapy
- •ECOG performance status of 0-1, with an expected ability to tolerate lying flat for half an hour.
排除标准
- •Patients who have undergone cervical cancer surgery, excluding pelvic lymphadenectomy or pelvic lymph node dissection, or cervical conization
- •FIGO stages IA, IIIC2, IVA, or IVB
- •FIGO stage IIIC1 with lymph nodes >2 cm, or with common iliac lymph node metastasis
- •History of prior abdominal or pelvic radiotherapy
- •Pregnant or breastfeeding women
- •Patients with active infections or fever
- •Other severe diseases that may significantly affect clinical trial compliance, such as unstable heart disease, kidney disease, chronic hepatitis requiring treatment, poorly controlled diabetes, or mental disorders.
结局指标
主要结局
Progression Free Survival
时间窗: 3 years
Defined as time from date of randomization to date of progression, date of death from any cause, or date of last follow-up, whichever occurs first. Cancer progression can be identified during physical exam, biopsy, or imaging of any kind.
次要结局
- Acute toxicity(3 months)
- Late toxicity(3 years)
- Overall survival(3 years)
- Quality of life (QoL)(3 years)
- Quality of Life (QoL)(3 years)
- Locoregional progression-free survival(3 years)
- Tumor response evaluation Complete remission rate(3 months)
- Metastasis-free survival(3 years)
- Cervical cancer-specific survival(3 years)
- Treatment expense(3 months)