Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging: Multi-center, Randomized Phase-II-trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 276
- 试验地点
- 16
- 主要终点
- local tumour control
研究概览
简要总结
The trial evaluates the value of radiation dose escalation based on Hypoxia detection by 18F_misonidazole Positron Emission Tomography (18F-MISO-PET) for primary radiochemotherapy of head and neck squamous cell carcinoma. Patients negative for human papillomavirus (HPV) and with hypoxic tumours after 2 weeks of radiochemotherapy are randomized to completion of standard radiochemotherapy or radiochemotherapy with escalated radiation dose. An additional interventional arm includes a carbon ion boost. HPV positive tumours can be included in a control arm. Primary endpoint is local tumour control 2 years after radiochemotherapy.
详细描述
Previous preclinical data and a prospective validated patient cohort have shown that patients with head and neck squamous cell carcinoma, whose tumours are hypoxic after 2 weeks of primary radiochmeotherapy, have a significantly lower chance of locoregional tumour control. The multi-center trial evaluates the value of radiation dose escalation based on hypoxia detection by 18F_misonidazole Positron Emission Tomography (18F-MISO-PET) for primary radiochemotherapy of head and neck squamous cell carcinoma. Patients negative for human papillomavirus (HPV) and with hypoxic tumours after 2 weeks of radiochemotherapy are randomized to completion of standard radiochemotherapy (70 Gy) or radiochemotherapy with escalated radiation dose (77 Gy). An additional interventional arm includes a carbon ion boost to 77 Gy. HPV positive tumours can be included in a control arm. Primary endpoint is local tumour control 2 years after radiochemotherapy. Secondary endpoints include acute and late toxicity (CTCAE 5.0), regional tumor control, overall survival, disease free survival, distant metastases, kinetics analysis of dynamic FMISO-PET scans, Quality of life (QoL). The hypothesis is that local tumour control 2 years after radiochemotherapy is higher in the dose escalated compared to the control arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Age: older than 18 years
- •WHO (ECOG) performance status 0-2
- •Histological proven HNSCC
- •HPV negative tumors or HPV positive tumors
- •Stage III, IVA or IVB HNSCC according to UICC and AJCC guidelines
- •Tumor classified as irresectable or patient inoperable or patient refused surgery
- •Tumor extension and localization suitable for radiochemotherapy with curative intent
- •Simultaneous standard chemotherapy with cisplatin applicable (no contra-indications)
- •Dental examination and -treatment before start of therapy
- •For women with childbearing potential and men in reproductive ages adequate contraception.
- •Ability of subject to understand character and individual consequences of the clinical trial
- •Written informed consent (must be available before enrolment in the trial)
排除标准
- •Refusal of the patients to take part in the trial
- •Presence of distant metastases (UICC stage IVC)
- •Previous radiotherapy in the head and neck region
- •Second malignancy that is likely to require treatment during the trial intervention or follow-up period or that, in the opinion of the physician, has a considerable risk of recurrence or metastases within the follow-up period
- •Serious disease or medical condition with life expectancy of less than one year
- •Participation in competing interventional trial on cancer treatment
- •Patients who are not suitable for radiochemotherapy
- •Pregnant or lactating women
- •Patients not able to understand the character and individual consequences of the trial
- •Nasopharyngeal Carcinomas
结局指标
主要结局
local tumour control
时间窗: Local tumor control 2 years after end of treatment
Local tumour control (MRI, CT, PET or clinical evaluation) in the randomized dose-escalated arm compared to the randomized non dose escalated arm (arms 1 and 2).
次要结局
- late toxicity(30 days to 2 years after radiochemotherapy)
- survival(2 years after radiochemotherapy)
- quality of life EORTC QLQ-C30/HN-35(regularly up to 2 years after radiochemotherapy)
- acute toxicity(during treatment and up to 30 days after radiochemotherapy)
研究者
Mechthild Krause
Director of the Department of Radiotherapy and Radiation Oncology
Technische Universität Dresden