Intra-lesional Tumor Boost for Bulky Cervical Cancer

Phase 2RecruitingNCT07435376

Seoul National University Bundang Hospital17 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Cancer Squamous Cell Carcinoma of Cervix

Interventions

intra-lesional boost IMRTRADIATION

Patients receive Whole Pelvis (+/- para-aortic field) radiotherapy 45-50.4 Gy in 25-28 fractions. An intra-lesional boost is delivered using SIB technique: 15 Gy in 3 fractions to the boost target (GTVp minus 0.7-1.0 cm margin).

High Dose Rate BrachytherapyPROCEDURE

Followed by CT or MRI-based HDR brachytherapy. Recommended dose is 27.5-30 Gy in 4-6 fractions to the HR-CTV using Iridium-192 source.

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of Participants With Tumor Volume < 12 cc Before Brachytherapy

Tumor volume is measured using pelvic MRI volumetric analysis to determine if the intra-lesional boost successfully reduces the target volume below 12 cc.

Time frame: At 4 to 5 weeks after the start of radiation therapy (specifically at the time of 20-25 fractions)

Secondary Outcomes

Complete Remission (CR) Rate

Defined as the disappearance of all lesions on cervical examination and imaging tests.

Time frame: From treatment completion up to 2 years

Locoregional Control Rate

Defined as the absence of tumor recurrence in the locoregional area confirmed by biopsy or imaging.

Time frame: From treatment completion up to 2 years

Progression-Free Survival (PFS)

Assessed using the Kaplan-Meier method.

Time frame: From date of enrollment to progression or death, assessed up to 2 years

Overall Survival (OS)

Assessed using the Kaplan-Meier method.

Time frame: From date of enrollment to death from any cause, assessed up to 2 years

Incidence of Treatment-Related Adverse Events

Assessed and graded according to NCI-CTCAE version 6.0.

Time frame: From the start of treatment up to 2 years