PHASE II PROSPECTIVE RANDOMIZED TRIAL OF THE BOOST TREATMENT OF CHEMO-RADIOTHERAPY GUIDED BY PERFUSION MRI IMAGING ON HYPOXIC ZONES IN HEAD AND NECK CANCER
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- Complete response
研究概览
简要总结
To assess and localize hypoxic tumor subregions both at baseline and during the second week of radiotherapy. And to hypothesize that an intensified IMRT regimen may ensure higher local response rates compared to the standard IMRT approach.
详细描述
A randomized, prospective, phase II study conducted with the aim of evaluating whether the strategy of overdosing hypoxic sub-regions of the primary tumor is associated with better local control compared to standard chemoradiotherapy for squamous cell carcinomas of the head and neck.
To evaluate whether side effects are influenced by the MRT approach. To search for initial (pre-treatment) hypoxic regions during treatment (at the 10th fraction of RT) in terms of volume and location. And finally to determine the prevalence and importance of pre-treatment hypoxic sub-regions and correlate the results with both clinical (primary site and tumor volume) and pathological (VEGF, EGFR and HIF-α expression in the primary tumor) characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx;
- •AJCC stage III or IV (cT2-4 N0-3 M0);
- •specific informed consent.
排除标准
- •Documented allergy to radiological contrast media or inability to receive contrast media due to concomitant pathology (e.g. renal);
- •inability to receive radiotherapy (e.g. previous radiotherapy in the same region) and/or chemotherapy (inadequate bone marrow and/or liver and/or renal function);
- •incomplete acquisition of MRI images;
- •performance status 2 or more according to Zubrod;
- •Previous invasive neoplasm (except skin cancer), except for neoplasms controlled for at least three years; non-invasive tumors (e.g. carcinoma in situ of the breast) are admitted even if diagnosed and treated in a period less than 3 years prior; patients with simultaneous or bilateral primary tumors are excluded;
- •alcohol or drug abuse;
- •legal incapacity or limited legal capacity;
- •concomitant treatment with investigational drugs or participation in another clinical trial with use of investigational drugs within 30 days prior to screening for the study;
- •documented hypersensitivity to study drugs or any of their excipients;
- •pregnancy and/or breastfeeding.
研究组 & 干预措施
stIMRT standard IMRT regimen
In this treatment arm, chemoradiotherapy will be administered at doses of 70 Gy, 63 Gy and 58.1 Gy will be administered to PTV1, PTV2 and PTV3 respectively in 35 fractions (5 fractions per week) with simultaneous integrated boost (SIB) technique.
Chemotherapy will consist of i.v. cisplatin on days 1, 22, 43, at a dose of 100 mg/m2. Hydration and antiemetics are controlled according to the Institute guidelines.
干预措施: Cisplatin IV on days 1, 22, 43, at a dose of 100 mg/m2 (Drug)
deIMRT intensified IMRT regimen
In the IMRT arm, the baseline HV dose (HV1) is further increased by 10% up to 77 Gy in 35 fractions (5 fractions per week) using SIB technique (2.2 Gy/fraction). Once the MR2 is performed at the 10th fraction, the hypoxic volumes (HV2) will be re-estimated and coregistered with the initial planning CT, if the HV2 is within the HV1, no change will be applied; if new hypoxic volumes are identified outside the initial HV1 volume, the plan will be adapted to boost these regions as well.
Chemotherapy will consist of i.v. cisplatin on days 1, 22, 43, at a dose of 100 mg/m2. Hydration and antiemetics are controlled according to the Institute guidelines.
干预措施: Cisplatin IV on days 1, 22, 43, at a dose of 100 mg/m2 (Drug)
结局指标
主要结局
Complete response
时间窗: 2 years
Complete response is defined as complete disappearance (100%) of tumor at any site (primary and nodal) on both physical examination and imaging. Any site (primary or nodal) suspicious for residual disease on re-evaluation imaging or physical examination will be confirmed by pathology
次要结局
未报告次要终点