A Feasibility and Safety Study of Single Application Multi-fractionated High Dose Rate (HDR) Brachytherapy in Locally Advanced Cervical Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of participants achieving specified dosimetric constraints
研究概览
简要总结
The purpose of the study is to evaluate safety and feasibility of single brachytherapy application with dose delivery in multiple fractions. Study will be conducted in Phase I/II clinical trial setting with strict Image guidance protocol.This study is expected reduce treatment duration and to increase ease and acceptability of brachytherapy in patients along with significant saving of resources
详细描述
Brachytherapy for cervical cancers has evolved a long way from the era of Manchester based point A prescription to volume-based prescription in the current era of 3 Dimensional (3D) imaging. Advancement in imaging technology and widespread availability of this technology has allowed most centers worldwide to incorporate Image guided brachytherapy as a routine part of their clinical practice.
The primary advantage of 3D image guided brachytherapy is that it allows the dose given by brachytherapy to conform to the anatomy of each individual patient while reducing the doses to organs at risk (OAR) (1). This technique has shown to improve local control rates and also reduce the rates of moderate to severe morbidity in multiple single institutional series (2-6). However, treatment related urinary and gastrointestinal late morbidity is still a significant problem with the 3 year actuarial incidence of intermediate to major morbidity (Grade≥2) being 30% and 29% for urinary and gastrointestinal side effects, respectively and Major morbidity (Grade≥3) is seen in 7% and 8%, respectively [An intErnational study on MRI guided BRachytherapy in locally Advanced CErvical cancers (EMBRACE) study 2014, work in progress(7)].
Most important factor determining late toxicities in radiotherapy is dose per fraction and total dose (total BEDGy3) rather than rate of dose accumulation or number of applications, which is evident from many trials of HDR brachytherapy.
The dose per fraction in the protocol of 9Gy, 7Gy and 7Gy HDR is effective in terms of local control rates and toxicities which has been published(8,9).
Our study is designed to evaluate the feasibility to deliver complete course of HDR brachytherapy in a single application while achieving dose constraints to OARs and keeping in account inter-fraction variation of doses to OAR's.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed invasive cervical cancer (squamous carcinoma, adenosquamous carcinoma, adenocarcinoma)
- •International Federation of Gynecology and Obstetrics (FIGO) stage 2b-4a after thorough clinical examination and work-up investigation
- •Suitable for radical radiation therapy with/without chemotherapy, and also for brachytherapy boost
- •Accepts the Informed consent process and signs the form on his/her will.
排除标准
- •Patients with vesico-vaginal fistula or recto-vaginal fistula at diagnosis
- •Patients at high risk of anaesthesia and patients with phobia /contra-indications to undergo MRI
- •Patients not suitable for brachytherapy
- •Metastatic disease beyond iliac on standard imaging
- •Vault cancers/recurrence
- •Previous history of pelvic radiation
- •Non-compliance to treatment
- •Medical or psychological illness precluding treatment protocol
研究组 & 干预措施
Single application brachytherapy
After external beam radiotherapy with or without chemotherapy as per standard, each study patient will undergo single application brachytherapy to deliver 3 High Dose Rate (HDR) fractions [1st, 2nd and 3rd fractions of doses 9 Gy, 7 Gy and 7 Gy respectively] keeping 6-12 hours of interval. All patients will undergo an inter-fraction Computed Tomography (CT) scan before delivery of second fraction. Plan will be re-optimized to reduce the dose to Organs at Risk (OAR's), only if the dose exceeds the dose constraints. Dose constraints being exceedingly hard in 1st fraction or before 2nd fraction even after re-planning will deem patient non-feasible but optimization will be done to give preference to OAR's while accepting some compromise in target doses.
干预措施: Single application multi-fraction brachytherapy (Radiation)
结局指标
主要结局
Number of participants achieving specified dosimetric constraints
时间窗: 1 year
Number of participants achieving protocol specified dosimetric constraints will be measured, these dosimetric constraints are considered as a measure of safety. If not more than 20% of participants fail to achieve dosimetric constraints, trial will be considered feasible.
次要结局
- Local control rate(2 years)
- Number of participants with adverse events as assessed by CTCAE v 4.0(2 years)
- Percentage Inter-fraction dose variation(1 year)
研究者
Dr Umesh Mahantshetty
Professor
Tata Memorial Hospital