Hydrogel spacer to protect the rectum during cervical cancer radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-center, single-arm trial, about 30 women with newly diagnosed cervical cancer will receive an absorbable hydrogel spacer prior to their standard definitive radiotherapy, which includes external beam radiotherapy and image-guided brachytherapy. The spacer’s position, thickness, and stability will be tracked with serial MRI and CT imaging throughout treatment. Researchers will compare rectal dose and other nearby organs at risk, along with target coverage, across the treatment course. Safety and feasibility of implanting the spacer will also be evaluated. The primary endpoint is the cumulative rectal dose (D2cc in EQD2) over the full radiotherapy regimen.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Yuanjie Cao, MD — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Yuanjie Cao, MD
• Email: cyjro325@tjmuch.com
• Phone: 86+18522123151

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.