Hydrogel spacer to protect the rectum during radiotherapy for cervical cancer
Tests a gel placed beside the rectum during radiotherapy for cervical cancer.
Plain-language title generated from the registry record
Registry title: Hydrogel Spacer During Definitive Radiotherapy for Cervical Cancer
Key facts
- Where
- Tianjin, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with cervical cancer who have not been treated yet and will have radiotherapy with brachytherapy. A hydrogel spacer is placed between the cervix or vagina and the rectum before treatment.
- Age
- 18 to 75 years (the registry lists a minimum age of 17 years).
- Sex
- Women only.
- Disease stage
- Cervical cancer confirmed by tissue examination, planned for definitive external radiotherapy combined with brachytherapy. The body anatomy must allow placing the spacer.
- Earlier treatment
- No previous treatment for this disease and no earlier radiotherapy to the pelvis.
Main reasons for not taking part
- Earlier pelvic radiotherapy
- Pregnancy or breastfeeding
- Active pelvic infection, fever or other acute condition
- Fistula between rectum and vagina, obvious cancer growth into the rectal wall, or severe rectal inflammation
- Severe bleeding or clotting problem, or a severe allergy to the product
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 17 and 75 years old?
Source: NCT07904182, who can take part
Where in China
- Tianjin Medical University Cancer Institute and HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tianjin Medical University Cancer Institute and Hospital
- Trial code
- NCT07904182
- Record updated
- 29 October 2026
- Original description
This prospective, single-center study will evaluate the feasibility, spatial stability, and dosimetric effects of an absorbable hydrogel spacer placed between the cervix/vagina and rectum before definitive radiotherapy for cervical cancer. Approximately 30 participants will receive hydrogel spacer implantation before the first fraction of external beam radiotherapy (EBRT), followed by standard definitive radiotherapy including EBRT and image-guided brachytherapy (IGBT).Read full original descriptionShow less
A Prospective Single-Center Study of Absorbable Hydrogel Spacer for Whole-Course Radiotherapy in Cervical Cancer: Feasibility, Spatial Stability, and Dosimetric Outcomes
This prospective, single-center study will evaluate the feasibility, spatial stability, and dosimetric effects of an absorbable hydrogel spacer placed between the cervix/vagina and rectum before definitive radiotherapy for cervical cancer. Approximately 30 participants will receive hydrogel spacer implantation before the first fraction of external beam radiotherapy (EBRT), followed by standard definitive radiotherapy including EBRT and image-guided brachytherapy (IGBT).
Serial magnetic resonance imaging (MRI) and computed tomography (CT) will be used to assess spacer position, thickness, and stability throughout treatment. Radiation doses to the rectum and other organs at risk will be evaluated across the full course of radiotherapy. The primary objective is to assess the effect of the hydrogel spacer on cumulative rectal dose while maintaining adequate target coverage. Procedure-related safety and feasibility will also be evaluated.
Inclusion: Female participants aged 18 to 75 years; Pathologically confirmed cervical cancer planned for definitive external beam radiotherapy combined with brachytherapy; Previously untreated disease with no prior pelvic radiotherapy; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and considered by the investigator to be able to complete definitive radiotherapy; Able to undergo pelvic magnetic resonance imaging (MRI) and other imaging examinations required by the study before treatment; Anatomical conditions considered suitable by imaging and investigator assessment for hydrogel spacer implantation between the posterior cervix/vaginal wall and the anterior rectal wall; Able to understand the study, willing to participate, and able to provide written informed consent.
Exclusion: Prior pelvic radiotherapy or other prior radiotherapy considered likely to substantially affect dosimetric evaluation in this study; Active pelvic infection, fever, or other acute condition making an invasive procedure unsuitable; Rectovaginal fistula, obvious rectal wall invasion, severe rectal inflammation, or other conditions considered by the investigator to substantially increase the risk of rectal perforation or fistula associated with spacer implantation; Severe coagulation abnormality or an uncorrectable bleeding risk; Severe cardiac, pulmonary, hepatic, renal, or other systemic disease considered by the investigator to prevent completion of treatment or study follow-up; Known history of severe allergy to components of the study product; Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study; Pregnancy or breastfeeding.