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Intra-lesional Tumor Boost for Bulky Cervical Cancer

RECRUITINGPhase 2Sponsored by Seoul National University Bundang Hospital
Actively Recruiting
PhasePhase 2
SponsorSeoul National University Bundang Hospital
Started2025-02-23
Est. completion2026-09-30
Eligibility
Age19 Years – 80 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 19 Years – 80 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Conditions3

CancerCervical CancerSquamous Cell Carcinoma of Cervix

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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