FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Complete response rate
研究概览
简要总结
Hypoxia occurs in about 80% of head and neck tumors. Based on experimental and clinical data, hypoxia is a useful parameter for pretherapeutic stratification. These radioresistant regions can be detected with FMISO PET/CT. Moreover, hypoxic subvolumes of tumors can be evolving as target volumes for radiotherapy ("dose painting") in hypoxia imaging-based dose escalation.
详细描述
The radiotherapy protocol will include two dose-escalation regimens. The dose in hypoxic tumor volume will be escalated either by conventional RT or stereotactic radiotherapy technique. Concurrent chemotherapy cisplatin will be administered weekly 35-40 mg/m2 or every three weeks 80-100 mg/m2. The parameter of cumulative cisplatin dose of 200 mg/m2 during the whole course of radiotherapy will be also taken into account. Patients will be examined and monitored at least every two weeks.
Target volumes and dose and fractionation:
Definition of gross tumor volumes (GTV), clinical target volumes (CTV) and planning target volumes (PTV) will follow recommendations of DAHANCA, EORTC and RTOG guidelines.
The conventional radiotherapy protocol:
Standard fractionation regimen: 70 Gy/54 Gy in 33 fractions GTV primary - CTV - PTV (5+5mm): for dose 70 Gy in 33 fractions GTV LN bulky (> 3cm) - PTV (5mm): for dose 70 Gy in 33 fractions LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy in 33 fractions
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
- •Pathologically proven new diagnosis of oropharyngeal p16 negative, or laryngeal, hypopharyngeal, oral cavity (independent of p16) squamous cell carcinoma of clinical stage III, IV confined to head and neck area
- •Evaluable tumor burden assessed by computed tomography scan or magnetic resonance imaging, based on RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1
- •Eligibiity for definitive chemoradiation or hyperfractionated accelerated radiotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate kidney and liver function
排除标准
- •Prior surgical treatment - any surgery of primary tumor or involved nodes or prior surgical debulking apart from surgery with diagnostic intention (e.g. open biopsy if necessary)
- •Prior systemic therapy, targeted therapy, radiotherapy treatment for head and neck cancer
- •Cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or unknown primary head and neck cancer
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or any distant metastasis
- •Known active Hepatitis B or C
- •History of Human Immunodeficiency Virus (HIV)
- •History of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
- •Previous allogeneic tissue/solid organ transplant
- •Active infection requiring systemic therapy
结局指标
主要结局
Complete response rate
时间窗: 2-year
response rate
Rate of late radiation-induced events according to CTCAE 5.0
时间窗: 2-year
late radiation-induced events
Rate of acute (<3 months) radiation-induced events according to CTCAE 5.0
时间窗: 3 months
acute radiation-induced events
Locoregional progresion free survival
时间窗: 2-year
locoregional progresion free survival
次要结局
- Distant metastasis free survival(4 years)
- Change in QoL according to the standardised EQ-5D questionnaire(2 years)
- Rate of new hypoxic areas after two weeks of radiotherapy(2 week after start of radiotherapy)
- Overall survival(4 years)
研究者
Martin Dolezel
Profesor Martin Dolezel, M.D., Ph.D.
University Hospital Olomouc