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RECRUITING
NCT07904182
NA

Hydrogel Spacer During Definitive Radiotherapy for Cervical Cancer

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective Single-Center Study of Absorbable Hydrogel Spacer for Whole-Course Radiotherapy in Cervical Cancer: Feasibility, Spatial Stability, and Dosimetric Outcomes

Key Details

Gender

FEMALE

Age Range

17 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-10-12

Completion Date

2028-09-30

Last Updated

2026-10-29

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Absorbable Hydrogel Spacer

An absorbable hydrogel spacer will be implanted between the posterior cervix/vaginal wall and the anterior rectal wall before the first fraction of external beam radiotherapy (EBRT). The spacer is intended to increase the physical separation between the target region and the rectum during definitive radiotherapy. Participants will subsequently receive standard definitive radiotherapy, including EBRT and image-guided brachytherapy (IGBT). The position, morphology, and stability of the spacer and its dosimetric effects will be evaluated throughout the course of treatment.

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China