Intra-lesional Tumor Boost for Bulky Cervical Cancer

Official title

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

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

Interventions

• Radiation intra-lesional boost IMRT
  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).
• Procedure High Dose Rate Brachytherapy
  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.

Primary outcome measures

• Proportion of Participants With Tumor Volume < 12 cc Before Brachytherapy [Time frame: At 4 to 5 weeks after the start of radiation therapy (specifically at the time of 20-25 fractions)]

Secondary outcome measures (5)

• Complete Remission (CR) Rate [Time frame: From treatment completion up to 2 years]
• Locoregional Control Rate [Time frame: From treatment completion up to 2 years]
• Progression-Free Survival (PFS) [Time frame: From date of enrollment to progression or death, assessed up to 2 years]
• Overall Survival (OS) [Time frame: From date of enrollment to death from any cause, assessed up to 2 years]
• Incidence of Treatment-Related Adverse Events [Time frame: From the start of treatment up to 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Seoul National University Bundang Hospital — Seongnam-si

Identifiers

NCT: NCT07435376 · KROG 24-03 · B-2410-931-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗