Assessing the feasibility, toxicities and efficacy of 18-FDG PET CT guided dose optimization for radiotherapy treatment in locally advanced cervix carcinoma- A Prospective Phase 2, Pilot study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- To assess proportions of patients achieving hard dose constraints for target and OAR Doses
研究概览
简要总结
Project title is Assessing the feasibility, toxicities and efficacy of 18-FDG PET CT guided dose optimization for radiotherapy treatment in locally advanced cervix carcinoma- A Prospective Phase 2, Pilot study
External beam pelvic radiotherapy with concurrent cisplatin-based chemotherapy and brachytherapy is standard of care for locally advanced uterine cervical cancer (LAUCC). Recently several studies have investigated the use of image-guided brachytherapy in cervical cancer, which help in optimizing radiation doses to post external beam radiotherapy target volume while minimizing normal tissue toxicity using three dimensional (3D) brachytherapy planning. Magnetic resonance imaging (MRI)-guided planning can give the best soft tissue resolution and is the method of choice for image-based brachytherapy; however, its use is limited by MRI availability and lack of availability of MR-compatible applicators, and the inability to use MRI guided planning in patients with metallic implants.
Some studies have been done utilizing metabolic tumor volume information from 18-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging for dose adaptation or dose escalation in LAUCC radiation planning. Many authors published regarding the use of FDG-PET with or without CT in brachytherapy planning, and the results of these studies demonstrated the feasibility of planning based on FDG-PET. Moreover PET gives additional baseline information about regional, distant metastases for staging purpose as well as information on metabolic treatment response post chemoradiotherapy. Recently Kim et al. reported its prognostic significance also in terms of poor disease-free survival and overall survival if post external beam radiotherapy, patients had change in tumor SUVmax (maximum standardized uptake value) less than 50% from baseline. In this study, we want to assess the feasibility toxicities and efficacy by using FDG-PET/CT guided dose-volume optimization of most commonly prescribed fractionation regimen in our department for pelvic external beam radiotherapy and brachytherapy in LAUCC.
To assess the feasibility toxicities and efficacy by using FDG-PET/CT guided dose-volume optimization of most commonly prescribed fractionation regimens in our department in LAUCC. There is limited experience on PET Guided Radiotherapy specially IGBT in India.
FDG-PET/CT guided dose-volume optimization in LAUCC is feasible, tolerable and efficacious and it can be considered as an alternative to MR guided image guided brachytherapy reported in literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Treatment naïve,
- •histopathologically proven carcinoma cervix (squamous/adeno/adeno-squamous),
- •International Federation of Gynecology and Obstetrics (FIGO) (2018) stage 1B-IIIC2 patients,
- •age 18-60 years,
- •attending gynecological tumor clinics, with ECOG performance status 0-2,
- •with adequate organ function and planned for definitive treatment with chemoradiotherapy and intracavitary brachytherapy.
- •Adequate organ function at time of participation.
排除标准
- •Patients with uncontrolled Diabetes mellitus, hypertension
- •Patients with HIV infection, Hepatitis B/C infection/ Active Tuberculosis/ any other systemic infection
- •Previously any pelvic surgery / partial or total hysterectomy
- •Previous pelvic/ abdominal radiotherapy
- •Patients with history of neoadjuvant chemotherapy
- •Patients with history of allergy to iodinated contrast or 18F-FDG
- •Patients requiring ISBT post external beam radiotherapy treatment
- •Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
- •Pregnancy
- •Patients with bladder or rectal invasion at diagnosis, vesico-vaginal fistula, or recto-vaginal fistula at diagnosis or post EBRT.
结局指标
主要结局
To assess proportions of patients achieving hard dose constraints for target and OAR Doses
时间窗: 3 months
To assess the proportions of patients developing grade 3 acute toxicity during or till 3 months post treatment
时间窗: 3 months
次要结局
- To assess PET based disease remission status at 3 months
研究者
Dr Pradeep Sadasivam
Jawaharlal Institute of Postgraduate Medical Education & Research