Evaluate the Effect of ReSpace™ Hydrogel on Reducing Rectal Radiation Dose in Radiotherapy for Cervical Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Uterine Cervical Neoplasms

Intervention / Treatment
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* Device: ReSpace™
* Device: gauze packing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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 ≥ 70. 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 Exclusion Criteria: •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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSpace™ & gauze packing<br>All of the subjects will undergo palcement of ReSpace™ hydrogel together with gauze packing in the vagina before brachytherapy | Device: ReSpace™<br>* The experimental group subjects will be injected with ReSpace™ hydrogel.<br>Device: gauze packing<br>* The subjects of both groups will be given gauze packing<br>|
| Active Comparator: gauze packing<br>All of the subjects will undergo palcement of gauze packing alone in the vagina before brachytherapy | Device: gauze packing<br>* The subjects of both groups will be given gauze packing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 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. | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during procedure | 
| The implantation success rate of hydrogel. | A successful injection means the hydrogel is placed between the cervical and rectum | 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. | 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. | 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. | during procedure | 
| 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# Whether the device is easy to assemble. Whether the process of positioning the needle is smooth and whether it is easy to position the needle. Whether the device is easy to inject and whether the injection process is smooth | during procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Cancer, Hydrogel Spacer