Using ReSpace™ Hydrogel to Reduce Rectal Radiation in Cervical Cancer Treatment

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

This study is testing if using ReSpace™ hydrogel during cervical cancer treatment can help protect the rectum from radiation damage.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05690906 on ClinicalTrials.gov

What this trial studies

This phase II clinical study aims to evaluate the effectiveness of ReSpace™ hydrogel in reducing radiation exposure to the rectum during brachytherapy for cervical cancer. The study will recruit 100 participants, dividing them into two groups: one receiving brachytherapy with hydrogel and the other without. The primary outcome will be the cumulative D2cc dose to the rectum, which will be compared between the two groups to assess the hydrogel's impact on radiation safety. The study will be conducted across multiple hospitals with national clinical trial qualifications.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 75 with pathologically confirmed cervical cancer scheduled for radical radiotherapy.

Not a fit: Patients who have previously received pelvic radiotherapy or have other primary malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce rectal radiation exposure for patients undergoing treatment for cervical cancer.

How similar studies have performed: While similar approaches have been explored, this specific use of ReSpace™ hydrogel in cervical cancer treatment is novel.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing

• Peking Union Medical College Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Fuquan Zhang, doctor

Conditions: Uterine Cervical Neoplasms, Cervical Cancer, Hydrogel Spacer