Hydrogel Spacer During Definitive Radiotherapy for Cervical Cancer

Prior treatment

• Prior pelvic radiotherapy or other prior radiotherapy considered likely to substantially affect dosimetric evaluation in this study.

Other illness

• 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.

Other

• Pregnancy or breastfeeding.

• 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.