Intra-lesional Tumor Boost for Bulky Cervical Cancer

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

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

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.