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临床试验/CTRI/2025/05/086522
CTRI/2025/05/086522尚未招募不适用

Assessment of treatment outcomes using Image Guided Adaptive Brachytherapy (IGABT) for cervical cancer

Dr Rahul1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2025年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
49
试验地点
1
主要终点
Assessment of tumor outcomes using image guided brachytherapy

研究概览

简要总结

Cervical cancer is the fourth most common cancer among women globally, particularly in low- and middle-income countries where screening and vaccination programs are less accessible. According to the World Health Organization (WHO), there are approximately 570,000 new cases and 311,000 deaths from cervical cancer each year. Cervical cancer is primarily caused by persistent infection with high-risk human papillomavirus (HPV) types, and the disease progresses through pre-cancerous lesions to invasive carcinoma if untreated..Brachytherapy (BT) is a cornerstone in the management of locally advanced cervical cancer, especially for stages IB2 to IVA as per the FIGO classification. It involves the direct placement of radiation sources within or near the tumor site, allowing high-dose radiation delivery to the tumor while sparing surrounding healthy tissues. Brachytherapy has been shown to improve local control and survival rates, complementing external beam radiotherapy (EBRT) and chemotherapy as part of a curative treatment regimen. Traditional 2D X-ray-based brachytherapy has limitations in terms of precision and the ability to adapt dose distributions to the tumor’s shape and location. Conventional methods use predefined anatomical points (e.g., point A) as surrogates for tumor location, leading to dose variability and inaccuracies, especially in large or irregularly shaped tumors. This often results in suboptimal dose delivery to the tumor, insufficient sparing of surrounding organs-at-risk (OARs), and consequently, an increased risk of complications and recurrence. In response to the limitations of conventional brachytherapy, Image-Guided Adaptive Brachytherapy (IGABT) has been developed as a more precise approach that incorporates imaging to guide radiation placement. The technique uses MRI or CT imaging to delineate the tumor and surrounding structures in three dimensions, allowing for individualized treatment planning and dose adaptation based on the tumor’s response to external beam radiation therapy (EBRT). IGABT allows higher doses to the tumor while minimizing exposure to OARs like the bladder, rectum, and sigmoid colon, improving the therapeutic ratio.This study follows the guidelines by GEC-ESTRO for target volume delineation, dose constraints, and adaptive planning in IGABT and evidences by EMBRACE on local control and survival rates in cervical cancer patients by IGABT in comparison to conventional brachytherapy

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • •Histologically confirmed diagnosis of cervical cancer (FIGO stages IB to IVA).
  • •Patients planned for chemoradiotherapy followed by IGABT.
  • •Patients who consent to imaging-based brachytherapy (MRI or CT).
  • •Age: 18 years and above with ECOG performance status ECOG less than or equal to 2.

排除标准

  • •History of prior pelvic irradiation Pregnancy and lactation Any contraindication for CT and MRI imaging Poor performance status(ECOG more than 2) Patients with coexisting malignancies.

结局指标

主要结局

Assessment of tumor outcomes using image guided brachytherapy

时间窗: Assessment at 1st month, 3rd month and 6th months

次要结局

  • To assess the impact of IGABT on treatment related toxicity & patient quality of life(at 1 month 3 month & 6 month)

研究者

发起方
Dr Rahul
申办方类型
Other []

研究点 (1)

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