💬In plain words
What the trial is, and whether it could suit you
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-relate
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Female participants aged 18 to 75 years.
2. Pathologically confirmed cervical cancer planned for definitive external beam radiotherapy combined with brachytherapy.
3. Previously untreated disease with no prior pelvic radiotherapy.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and considered by the investigator to be able to complete definitive radiotherapy.
5. Able to undergo pelvic magnetic resonance imaging (MRI) and other imaging examinations required by the study before treatment.
6. Anatomical conditions considered suitable by imaging and investigator assessment for hydrogel spacer implantation between the posterior cervix/vaginal wall and the anterior rectal wall.
7. Able to understand the study, willing to participate, and able to provide written informed consent.
Exclusion Criteria:
1. Prior pelvic radiotherapy or other prior radiotherapy considered likely to substantially affect dosimetric evaluation in this study.
2. Pregnancy or breastfeeding.
3. Active pelvic infection, fever, or other acute condition making an invasive procedure unsuitable.
4. 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.
5. Severe coagulation abnormality or an uncorrectable bleeding risk.
6. Severe cardiac, pulmonary, hepatic, renal, or other systemic disease considered by the investigator to prevent completion of treatment or study follow-up.
7. Known history of severe allergy to components of the study product.
8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
💊
What it tests
- Absorbable Hydrogel Spacer
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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