A Prospective Study of Spatially Fractionated Radiation Treatment Using Rapid Rod Technique for Gynaecological Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- In-field control
研究概览
简要总结
This is a prospective study to evaluate in-field disease control, survival and late toxicity in patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT.
The study will include patients with primary cervical cancer or pelvic recurrence not suitable for brachytherapy in view of anticipated or actual suboptimal target coverage due to aberrant anatomy or large residual disease at the time of brachytherapy.
详细描述
Patients will be treated with spatially fractionated radiation therapy (SFRT) after EBRT completion to a dose of 25-30 Gy in 5-6 fractions in the primary setting. For patients receiving re-irradiation, 20-25 Gy in 4-5 fractions will be delivered with SFRT, which however may be individualised to match with clinical practice in the re-RT setting. Total EQD2 Gy for organs at risk will be matched to brachytherapy.
The study will be conducted at Tata Memorial Hospital, Mumbai and Advanced Centre for Treatment, Research and Education In Cancer (ACTREC), Navi Mumbai.
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
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with cervical cancer post EBRT, with expected suboptimal brachytherapy dose coverage due to-
- •Aberrant uterine or pelvic anatomy leading to difficulty in localization of the cervical OS or negotiation of the uterine canal accurately by two independent clinicians in up to two procedures.
- •Large residual disease at the time of brachytherapy with anticipated suboptimal target coverage either determined in clinic based on pre-brachytherapy imaging or at dose planning (e.g. figure 2).
- •Very narrow vaginal canal not accommodating even the smallest intracavitary or vaginal cylinder applicators.
- •Patients with inoperable endometrial cancer not suitable for anaesthesia or have anticipated suboptimal coverage of target volume at brachytherapy as identified on pre-brachytherapy imaging obtained after EBRT.
- •Patients with large pelvic recurrences after surgery and/or (chemo) radiation, not amenable to surgical salvage or brachytherapy after salvage EBRT due to reasons specified in item
- •Patients with contraindications to anaesthesia for brachytherapy with sufficient risk of on-table or post procedure adverse events.
排除标准
- •Any pre-existing fistula in bladder or rectum.
- •Pelvic prosthesis.
- •Refusal to provide consent.
研究组 & 干预措施
SFRT arm
This is a single arm phase II study. All patients will receive the planned intervention ie. spatially fractionated radiation therapy using rapid rod technique.
干预措施: Spatially fractionated radiation therapy (Radiation)
结局指标
主要结局
In-field control
时间窗: 1-year
To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT
次要结局
- To obtain biopsy tissue for translational research before and after SFRT(1-year)
- To compare SFRT in-silico dose volume parameters with proton beam plans(1-year)
- Progression-free and overall survival(2-years)
- Late grade 2 or higher genitourinary and gastrointestinal toxicities.(> 90 days)
- To study overall response in reference to PET FDG and Hypoxia imaging at baseline and before SFRT(1-year)
研究者
Supriya Sastri (chopra)
Dr Supriya Sastri
Tata Memorial Hospital