A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Clinical Study to Evaluate the Effect of ReSpace™ Hydrogel on Reducing Rectal Radiation Dose in Radiotherapy for Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The cumulative D2cc dose for rectum during brachytherapy
研究概览
简要总结
This phase II clinical study plan to recruit 100 subjects, 1:1 divide them into experimental group and control group, and the cumulative D2cc dose for rectum during brachytherapy will be recorded and compared.
详细描述
This phase II prospective, multicenter, randomized, parallel-controlled, superiority clinical study will select more than three hospitals with national clinical trial institution qualifications as clinical trial centers, plan to recruit 100 subjects, 50 in experimental group and 50 in control. The patients in expermental group will receive brachytherapy after the hydrogel injection while patients in control group will receive brachytherapy without hydrogel. The aim of the study was to evaluate whether the use of ReSpace™ hydrogel results in a reduction of radiation exposure to the anterior rectum, and to assess its safety.
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
- •• Patients with pathologically confirmed cervical cancer who must be scheduled to undergo radical radiotherapy by means of intensity-modulated radiotherapy combined with 3D brachytherapy.
- •Karnofsky score ≥
- •Subjects aged ≥ 18 years and ≤ 75 years.
- •Subjects must be able to cooperate in completing the entire study.
- •The subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate MRI.
- •No contraindications to CT scanning.
- •Subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form
排除标准
- ••Subjects who have received prior pelvic radiotherapy.
- •Subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.)
- •Subjects with other primary malignancies
- •Subjects with contraindications to radiotherapy, as determined by the investigators
- •Subjects with injection site infections.
- •Subjects who are allergic to the ingredients of the device.
- •Subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators
- •Persons with severe mental illness, cognitive impairment and thinking disorders.
- •Participants in other drug clinical trials or medical device clinical trials 1 month prior to screening
- •Pregnant or lactating women or those who plan to get pregnant within the last six months
- •Subjects who cannot be followed up as prescribed by the doctor
- •Other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollmen
结局指标
主要结局
The cumulative D2cc dose for rectum during brachytherapy
时间窗: during procedure
The mean of the cumulative rectum D2cc dose during brachytherapy will be calculated for subjects and be compared between the groups.
次要结局
- The implantation success rate of hydrogel.(during procedure)
- The stability of ReSpace™ Hydrogel(during procedure)
- QLQ-C30(during procedure)
- The cumulative D0.1cc, D5cc dose for rectum, and D0.1cc, D2cc, D5cc for sigmoid colon/small bowel during brachytherapy(during procedure)
- QLQ-CX24(during procedure)
- Evaluation of device performance of hydrogel spacer(during procedure)