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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Uterine Cervical Neoplasms

Treatments: Device: ReSpace™; Device: gauze packing

Study type: Interventional

Funder types: Other

Identifiers

NCT05690906

RN-CT-001-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

ReSpace™ & gauze packing

Experimental group

Description:

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

Treatment:

Device: gauze packing

Device: ReSpace™

gauze packing

Active Comparator group

Description:

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

Treatment:

Device: gauze packing