A Dose Escalation Study With Intensity Modulated Radiation Therapy (IMRT) in Moderately Advanced (T2N0, T2N1, T3N0) Squamous Cell Carcinomas (SCC) of the Oropharynx, Larynx and Hypopharynx Using a Simultaneous Integrated Boost (SIB) Approach.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- acute toxicity
研究概览
简要总结
The objective of the study is to assess the feasibility of increasing dose of irradiation with IMRT using a SIB approach over 6 weeks.
The primary endpoint of the study will be acute toxicity assessed during treatment and during the first 3 months following the completion of radiotherapy The secondary endpoint will include loco-regional control, disease-free survival, survival and late toxicity at 2 years after completion of radiotherapy
详细描述
Loco-regional failures remain a major concern following irradiation of locally advanced head and neck cancers. This has led radiation oncologists to investigate novel approaches offering better therapeutic indexes. Modification of dose fractionation schedules can improve the therapeutic outcome by using accelerated or hyperfractionated regimes -Ang, 1990; Ang, 1998; Fu, 2000; Gwozdz, 1997-. Intensity Modulated Radiation Therapy (IMRT) technique allows the planning and irradiation of different targets at different dose levels in a single treatment session, instead of successive treatment plans. With conventional 2D radiotherapy, both normal tissues and tumors are irradiated with a similar dose per fraction of 1.8-2 Gy, whereas with IMRT dose gradients are introduced in such a manner that normal tissues receive a much lower dose per fraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients older than 18 years
- •Patients with squamous cell carcinoma of the oropharynx, hypopharynx and larynx
- •Stage T2-N0-M0, T2-N1-M0 or T3-N0-M0
- •World Health Organization (WHO) Performance Status of 0 or 1 or Karnofsky performance status ≥
- •Provision of written informed consent
排除标准
- •Second primary tumor at the time of diagnosis
- •Previous history of malignant tumor in the last five years except basal cell carcinoma and carcinoma in situ of the cervix
- •Previous treatment with surgery, radiotherapy or chemotherapy for head and neck malignancy
- •Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or psychological disorder
- •Pregnant or lactating women
研究组 & 干预措施
Group 1 Patients
Radiotherapy Patients
干预措施: Radiotherapy (Drug)
结局指标
主要结局
acute toxicity
时间窗: during treatment and during the first 3 months following the completion of radiotherapy
acute toxicity
次要结局
- composite endpoint(from ratiotherapy until 2 years after completion of radiotherapy)