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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2023-07-31

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.

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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.

Conditions

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Uterine Cervical Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ReSpace™ & gauze packing

All of the subjects will undergo palcement of ReSpace™ hydrogel together with gauze packing in the vagina before brachytherapy

Group Type EXPERIMENTAL

ReSpace™

Intervention Type DEVICE

The experimental group subjects will be injected with ReSpace™ hydrogel.

gauze packing

Intervention Type DEVICE

The subjects of both groups will be given gauze packing

gauze packing

All of the subjects will undergo palcement of gauze packing alone in the vagina before brachytherapy

Group Type ACTIVE_COMPARATOR

gauze packing

Intervention Type DEVICE

The subjects of both groups will be given gauze packing

Interventions

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ReSpace™

The experimental group subjects will be injected with ReSpace™ hydrogel.

Intervention Type DEVICE

gauze packing

The subjects of both groups will be given gauze packing

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No