Intra-lesional Tumor Boost for Bulky Cervical Cancer

Официальное название

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

Обзор

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

Вмешательства

• Лучевая терапия 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).
• Процедура 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.

Первичные конечные точки

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

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Seoul National University Bundang Hospital — Seongnam-si

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗