Intra-lesional radiation boost for bulky cervical cancer

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

This phase 2 trial tests whether adding an intra-lesional radiation boost to standard pelvic chemoradiation helps shrink large cervical tumors more before brachytherapy and what side effects patients experience.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Ages: 19 Years to 80 Years
• Sex: Female
• Sponsor: Seoul National University Bundang Hospital (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Seongnam-si, Gyeonggi-do)
• Trial ID: NCT07435376 on ClinicalTrials.gov

What this trial studies

Adults with bulky squamous cell carcinoma of the cervix receive pelvic external-beam radiotherapy with a targeted intra-lesional boost using IMRT over about 5–6 weeks, typically with concurrent chemotherapy. Tumor size is measured by MRI during week 4 or 5 to determine whether the boost increases shrinkage prior to standard high-dose-rate brachytherapy. Investigators will record treatment-related side effects and monitor safety throughout and after therapy. This is a single-center phase 2 trial conducted at Seoul National University Bundang Hospital enrolling patients who meet the bulky-tumor and fitness criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19–80 with histologically confirmed squamous cell carcinoma of the cervix and a bulky primary tumor (≥60 cc or ≥6 cm), an ECOG performance status of 0–2, and who are fit for definitive concurrent chemoradiotherapy and able to give informed consent.

Not a fit: Patients who may not receive benefit include those with small tumors, non‑squamous histology, prior pelvic radiation or prior neoadjuvant chemotherapy, recent other malignancies, or who are medically unfit or unable to provide informed consent.

Why it matters

Potential benefit: If successful, the boost could increase tumor shrinkage before brachytherapy, improving local control and potentially reducing recurrence or the need for more aggressive treatments.

How similar studies have performed: Dose-escalation and simultaneous integrated boost approaches in cervical cancer have shown promising results in phase II and retrospective reports for improved local control, but intra-lesional boosting in this exact setting remains under active investigation.

Eligibility criteria

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.

Where this trial is running

Seongnam-si, Gyeonggi-do

• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (RECRUITING)

Study contacts

• Study coordinator: Keun-Yong Eom, MD, PhD

Conditions: Cervical Cancer, Squamous Cell Carcinoma of Cervix, cervical cancer, bulky cervical cancer, squamous cell carcinoma, intra lesional boost, simultaneous integrated boost, imrt