HYPOFRACTIONATED STEREOTACTIC RADIOTHERAPY/MULTISESSION RADIOSURGERY (HSFRT/MSRS) IN RESIDUAL/ RECURRENT NON SECRETING PITUITARY ADENOMAS AN EXPLORATORY STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Impact of the treatment on visual acuity
研究概览
简要总结
Single session stereotactic radiosurgery (SRS) is commonly used for patients with non-functioning adenomas. However the SRS can be limited by the proximity of the tumor with the surrounding critical structures (i.e., the optic chiasm).
The goal of the present prospective phase II trial is to investigate early and early delayed toxicity for cranial nerves and pituitary function after hypofractionated stereotactic radiotherapy/multisession radiosurgery (hSFRT/mSRS) in residual/ recurrent non secreting pituitary adenomas. Secondary end points are late toxicity and tumour growth local control.
All the enrolled patients will undergo radiosurgical treatment with a hypofractionation schedule Following radiotherapy, follow-up will be scheduled every 6 months during the first year post-radiosurgery and then annually, with the same tests.
The baseline examination and the follow-up assessment will include magnetic resonance imaging (MRI), full blood counts and blood chemistry tests, neuro-ophtalmology evaluation, physical and psychological examination that included a quality-of-life (EORTC Quol 30; BN 20) and a Hospital Anxiety and Depression Scale (HADS).
详细描述
Aims The main aim of our study is to analyze the effect of 5-session hypofractionated radiotherapy/multisession radiosurgery in treating NFAs in terms of toxicity and local control.
Study design This study is an exploratory study: patient's and treatment's data will be prospectively collected in a database and they will then be described and analyzed.
Criteria of analysis
All these points will be recorded and analyzed:
- Local control measured from the date of mSRS until progression or death, censored at the time of last clinical follow-up or imaging.
- Overall survival measured from the date of diagnosis until death, censored at the time of last clinical follow-up or imaging.
- Visual acuity improvement/worsening will be defined by reading increases/decreases equal of 1 or more lines; visual field will be considered improved or worsened for decreases or increase in the extension of the defect area. In order to compare pre- and post-treatment data, the results will be registered.
- Pituitary toxicity will be defined as a clinically relevant reduction compared to the baseline of ACTH, GH, TSH, testosterone in men, period disturbances in women, new onset of diabetes insipidus due to ADH deficiency. Hormonal changes will be defined relevant if a medical therapy change\introduction become mandatory.
- Other treatment-related toxicity based on CTCAE v4.0.
- Presence of adverse events based on CTCAE v4.0.
- Quality of life evaluated by "Quality of life EORTC - QLQ C30 and BN20" and "Hospital Anxiety and Depression Scale (HADS)". (25-28) (Appendix 1 and 2)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residual or progressive non secreting pituitary adenoma;
- •Exclusion of other treatment approach (second surgery, wait and scan; suppressive therapy) by a multidisciplinary team
- •Age ≥ 18 years; KPS ≥ 70
- •Written privacy consent;
- •Ability to give informed consent;
排除标准
- •Previous cranial irradiation;
- •Diagnosis of secreting adenoma;
- •pregnancy status;
- •unable to undergo MRI or CT scans;
- •unable to give informed consent.
研究组 & 干预措施
Radiosurgery
Patients suffering from residual/recurrent non functioning pituitary adenoma wil undergo to hypofractionated radiosurgery
干预措施: hypofractionated radiosurgery (Radiation)
结局指标
主要结局
Impact of the treatment on visual acuity
时间窗: From the treatment time to the 36th month post-treatment
\- Visual acuity (VA) improvement/worsening will be defined by reading increases/decreases equal of 1 or more lines (Vdetermined by the best performance on the Snellen Chart).
Early and late treatment related toxicity
时间窗: From the treatment to 36th month post-treatment
\- Treatment-related toxicity based on CTCAE v4.0.
Impact of the treatment on the visual field
时间窗: From the treatment time to the 36th month post-treatment
The visual field (VF) is a continuous quantitative variable described by the mean deviation (VFMD) value, which is a summary measure of vision average loss across the visual field. VFMD values at follow-up visits that are less negative than the baseline are considered an improvement, while more negative values are considered a worsening.
Impact of the treatment on the pituitary function
时间窗: From the treatment time to the 36th month post-treatment
Pituitary toxicity will be defined as a clinically relevant reduction compared to the baseline of ACTH, GH, TSH, testosterone in men, period disturbances in women, new onset of diabetes insipidus due to ADH deficiency. Hormonal changes will be defined relevant if a medical therapy change\\introduction become mandatory.
次要结局
- Tumor control(From the treatment time to the 36th month post-treatment)
- Impact of the treatment on the quality of life(From the treatment time to the 36th month post-treatment.)
- Impact of the treatment on anxiety and depression(From the treatment time to the 36th month post-treatment)