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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05690906
Study type Interventional
Source Peking Union Medical College Hospital
Contact Fuquan Zhang, doctor
Phone +86 13311360431
Email zhangfuquan3@126.com
Status Recruiting
Phase Phase 2
Start date July 12, 2022
Completion date July 2023

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