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A Prospective Phase 2 Clinical Trial of Intra-lesional Cervical Tumor Boost for Bulky Cervical Cancer

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to learn if adding a radiation boost (intra-lesional boost) works to treat patients with large-sized cervical cancer. It will also learn about the safety of this treatment. The main questions it aims to answer are: * Does the extra radiation boost effectively reduce the tumor size before the internal radiation (brachytherapy) treatment begins? * What medical problems (side effects) do participants have when receiving this treatment? Researchers will give this intra-lesional boost to all participants during their standard radiation therapy to see if it helps shrink the tumor more than usual. Participants will: * Receive radiation therapy to the pelvis with a targeted boost to the tumor for about 5 to 6 weeks * Visit the clinic daily for radiation treatment and regularly for checkups Have an MRI scan during the 4th or 5th week of treatment to measure the tumor size * Receive internal radiation therapy (brachytherapy) after finishing the external radiation * Visit the clinic for follow-up checkups and tests for up to 2 years

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients with histologically confirmed squamous cell carcinoma of the cervix.

• Patients with bulky primary tumor, defined as a tumor volume ≥ 60 cc OR a maximum diameter ≥ 6 cm.

• Patients aged 19 to 80 years at the time of diagnosis.

• Patients with an ECOG performance status of 0 to 2.

• Patients who have voluntarily agreed to participate in the study.

Locations
Other Locations
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Contact Information
Primary
Keun-Yong Eom, MD, PhD
978sarang@snubh.org
82-31-787-7653
Time Frame
Start Date: 2025-02-23
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 17
Treatments
Experimental: Intra-lesional Boost Group
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Bundang Hospital

This content was sourced from clinicaltrials.gov