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Intra-lesional Tumor Boost for Bulky Cervical Cancer

RecruitingPhase 2Ages 19 Years - 80 YearsFemaleSeoul National University Bundang Hospital
NCT07435376 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • intra-lesional boost IMRT
  • High Dose Rate Brachytherapy
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Where

1 site
Seoul National University Bundang Hospital
Seongnam-si, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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