Intra-lesional Tumor Boost for Bulky Cervical Cancer
Recruiting now · Phase 2
Conditions studied: Cervical Cancer, Squamous Cell Carcinoma of Cervix
In brief
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
Key facts
- Study ID
- NCT07435376
- Run by
- Seoul National University Bundang Hospital
- People needed
- 17
- Starts
- 2025-02-23
- Expected to finish
- 2028-11-30
- Last updated by the study team
- 2026-02-27
Who can join
Age: 19 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Diagnosis of other malignancies within 5 years prior to enrollment (Exceptions: carcinoma in situ of the breast and thyroid cancer).
- Patients who are medically unfit for definitive concurrent chemoradiotherapy.
- Patients who have received prior chemotherapy (neoadjuvant chemotherapy) before radiation therapy.
- Patients with prior history of radiation therapy to the abdomen or pelvis.
- Patients unable to provide informed consent due to mental or physical disabilities.
Where it is running
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (enrolling)
Full record on ClinicalTrials.gov
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