MR-PET Guided Biologically Optimised Interstitial Brachytherapy for Postoperative Recurrent Cervical Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Local Response in spatial reference to High Risk GTV (as identified by functional imaging)
研究概览
简要总结
The proposed two stage study will evaluate patterns of local recurrence after EBRT and brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The first stage of the study will focus on developing MR guided interstitial brachytherapy and validating the concept of high risk gross tumor volume (on the basis of functional imaging features).
The second stage thereafter will focus on developing biologically modulated interstitial brachytherapy.
In the proposed two staged study the investigators intend to prospectively evaluate and validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy. The demonstration of technical feasibility and clinical safety of biologically modulated image guided radiotherapy in this pilot study for may pave the way for improving local control in patients with postoperative recurrences.
详细描述
Aims
Stage I
Aim 1: To spatially characterize biologically heterogenous subvolumes within the gross tumor through multimodality (18 F-Miso/FLT/Functional MR) image fusion.
Aim 2: To evaluate post external beam radiotherapy (EBRT) response in spatial reference to biological heterogeneous sub-volumes on imaging.
Stage II:
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •ECOG 0 or
- •Residual/ Recurrent tumor after hysterectomy of cervical cancer.
- •No visceral metastasis.
- •No known contraindication to contrast enhanced MRI/PET scan.
- •Fit for radical treatment (radiotherapy+/-chemotherapy).
排除标准
- •Expected survival less than 3 years due to coexisting morbid medical conditions precluding radical chemoradiotherapy.
- •Inguinal or extra-pelvic nodal metastasis (Patients with common iliac nodal enlargement in the absence of paraaortic nodal metastasis on PET-CT may be included in the study).
结局指标
主要结局
Local Response in spatial reference to High Risk GTV (as identified by functional imaging)
时间窗: 3 months after treatment completion
次要结局
- Incidence of Grade III rectal and bladder toxicity with biologically dose modulated brachytherapy(2 years after treatment conclusion)
研究者
Supriya Sastri (chopra)
Associate Professor
Tata Memorial Hospital