A Phase I/II Study of the Use of Intensity Modulated Radiotherapy (IMRT) in Cancer of the Thyroid, Larynx and Hypopharynx
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- The primary endpoint is the number of patients with grade 3 or 4 complication at 12 months after treatment.
研究概览
简要总结
This study is a phase I/II dose escalation trial designed to test the feasibility of delivering IMRT to thyroid, larynx and hypopharynx cancer patients, and to assess the safety and possible improvement in outcome when the dose is increased.
This protocol is in fact two studies running in parallel: thyroid cancer patients and larynx/ hypopharynx cancer patients. These two groups of patients are being treated differently and will be analysed separately.
The primary objective of this Phase I sequential cohort study was to determine the feasibility of delivering modest acceleration and dose-escalated IMRT in locally advanced high-risk thyroid cancers. We report the incidence and prevalence of acute toxicities of 2 dose fractionation regimens.
DL1: primary site 58.8 Gy in 28 daily fractions and nodal levels 50 Gy in 28 daily fractions
DL2: primary 66.6 Gy in 30 daily fractions and post operative nodal levels 60 Gy in 30 daily fractions and elective nodal levels 54 Gy in 30 daily fractions
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Newly diagnosed histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck.
- •Newly diagnosed histologically confirmed papillary,follicular, undifferentiated or medullary carcinoma of the thyroid.
- •Tumours arising from the oral larynx or hypopharynx requiring radical radiation of the primary tumour by parallel opposed lateral fields, and bilateral cervical lymph node irradiation.
- •High risk of radiation induced xerostomia with conventional radiotherapy due to the irradiation of the majority of both parotid glands (defined as estimated mean dose to both parotid glands greater than 26 Gy using conventional radiotherapy technique).
- •Radiotherapy either as primary therapy or post-operative (only for thyroid carcinoma). Techniques to be detailed by each centre. Neo-adjuvant and concomitant chemotherapy are permitted.
- •Stage T1-4, N1-3, M0 disease
- •Zubrod Performance Status 0-2
排除标准
- •Previous radiotherapy to the head and neck region
- •Previous malignancy except non-melanoma skin cancer
- •Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
- •Prophylactic use of amifostine or pilocarpine is not allowed
- •Brachytherapy is not allowed as part of the treatment
结局指标
主要结局
The primary endpoint is the number of patients with grade 3 or 4 complication at 12 months after treatment.
时间窗: 12 months after radiotherapy
次要结局
- Loco-regional disease free survival (disease free thyroid bed, neck and superior mediastinum)(Up to 60 months after radiotherapy)
- Overall Survival(Up to 60 months after radiotherapy)
- Acute toxicity(Up to 3 months after radiotheapy)
- Local control(Up to 60 months after radiotherapy)
- Loco-regional control(Up to 60 months after radiotherapy)
- Late toxicity(Up to 60 months after radiotherapy)
- Disease free survival(Up to 60 months after radiotherapy)