Evaluating the long-term benefits of a hydrogel spacer in cervical cancer radiation therapy
A Prospective, Multicenter, Exploratory Clinical Study to Evaluate the Long-term Benefit of Hydrogel Spacer in Reducing Rectal Radiation Dose in Cervical Cancer Radiation Therapy.
This study is testing whether using a hydrogel spacer during radiation therapy can help women with cervical cancer by reducing radiation exposure to the rectum and improving their long-term health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05902390 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to assess the long-term benefits of using a hydrogel spacer to reduce rectal radiation exposure in women undergoing radiation therapy for cervical cancer. Participants from a previous study will be invited to enroll if they consent to long-term follow-up. The hydrogel is injected between the rectum and cervix to create a physical barrier, potentially minimizing radiation damage to surrounding tissues. The study will involve monitoring the outcomes of these patients over an extended period.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 75 with a Karnofsky score of 70 or higher, who are undergoing radiation therapy for cervical cancer.
Not a fit: Patients with prior treatments for their target tumors or those with contraindications to radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce rectal radiation exposure, improving the quality of life for cervical cancer patients undergoing treatment.
How similar studies have performed: Previous studies have shown promising results with hydrogel spacers in reducing radiation exposure, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Fuquan Zhang, Doctor
- Email: zhangfuquan3@126.com
- Phone: +86 13311360431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.