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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The experimental group subjects will be injected with ReSpace™ hydrogel.
The subjects of both groups will be given gauze packing
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe cumulative D2cc dose for rectum during brachytherapy
The mean of the cumulative rectum D2cc dose during brachytherapy will be calculated for subjects and be compared between the groups.
Time frame: during procedure
The cumulative D0.1cc, D5cc dose for rectum, and D0.1cc, D2cc, D5cc for sigmoid colon/small bowel during brachytherapy
The mean of the cumulative D0.1cc, D5cc dose for rectum, and D0.1cc, D2cc, D5cc for sigmoid colon/small bowel during brachytherapy will be calculated for subjects and be compared between the groups.
Time frame: during procedure
The implantation success rate of hydrogel.
A successful injection means the hydrogel is placed between the cervical and rectum
Time frame: during procedure
The stability of ReSpace™ Hydrogel
The maximum distance of cervical to rectum of different time during the procedure will be compared to assess the stability of hydrogel.
Time frame: during procedure
QLQ-C30
The EORTC QLQ-C30 questionaire will assessed among the subjects during the procedure, and comparioson will be made between the groups and inside the groups of different time. Scores range from 0 to 100, higher scores menas a better outcome.
Time frame: during procedure
QLQ-CX24
The EORTC QLQ-CX24 questionaire will assessed among the subjects during the procedure, and comparioson will be made between the groups and inside the groups of different time. Scores range from 0 to 100, higher scores menas a better outcome.
Time frame: during procedure
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Evaluation of device performance of hydrogel spacer
The ease of use of the test device will be evaluated by the investigator on the day of Operation. The evaluation items are as follows# 1. Whether the device is easy to assemble. 2. Whether the process of positioning the needle is smooth and whether it is easy to position the needle. 3. Whether the device is easy to inject and whether the injection process is smooth
Time frame: during procedure