Assessing Tumor Response and IMRT Treatment Planning After Induction Chemotherapy Based on FDG-PET/CT for Locally Advanced Head and Neck Squamous Cell Carcinoma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
To evaluate the safety and efficacy of cisplatin plus intensity-modulated radiotherapy (IMRT) based on FDG-PET/CT after induction chemotherapy (IC) for locally advanced head and neck squamous cell carcinoma.
详细描述
Current guidelines define that pre-IC target volumes must be used for radiotherapy (RT) planning. This prospective, phase II trial assessed the results of patients with locally advanced squamous cell carcinoma of head and neck treatment with IC following by chemoradiotherapy (CRT), using post-IC PET/CT images for IMRT planning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 years or over;
- •Histologically confirmed locally advanced (stage III and IV) head and neck squamous cell carcinoma (HNSCC);
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- •Signed written informed consent approved by the Lithuanian Bioethics Committee (LBEC);
排除标准
- •Positive serum pregnancy test in women of childbearing potential or breastfeeding;
- •Presence of distant metastasis;
- •Second primary tumor;
- •History of other malignancy within the last 5 years;
- •Recurrent head and neck cancer;
- •Serious uncontrolled concomitant disease that would contraindicate the use of any drugs use in this study as chemotherapy or radiotherapy; ;
- •Inadequate organ function, evidenced by the following laboratory results:
- •Absolute neutrophil count <1,500 cells/mm3;
- •Platelet count <100,000 cells/mm3;
- •Hemoglobin <9 g/dL;
- •Total bilirubin greater than the upper limit of normal (ULN);
- •AST (SGOT) or ALT (SGPT) >1,5 x ULN;
- •Alkaline phosphatase levels >2,5 x the ULN;
- •Serum creatinine >2,0 mg/dl or 177 umol/l.
研究组 & 干预措施
Experimental
Induction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly).
干预措施: IMRT (Radiation)
Experimental
Induction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly).
干预措施: PET/CT (Radiation)
Experimental
Induction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly).
干预措施: Docetaxel (Drug)
Experimental
Induction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly).
干预措施: Fluorouracil (Drug)
Experimental
Induction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly).
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 24 months after treatment
PFS was defined as the time from the first day of IC first cycles to either progression or death.
次要结局
- SUVmax reductions (%)(2 weeks after IC)
- Number (%) of participants with adverse events(12 and 24 months from chemoradiotherapy)
- Overall survival (OS)(24 months after treatment)
- Tumour metabolic response (MTV) reduction (%)(2 weeks after IC)
- Total lesion glycolysis (TLG) reduction (%)(2 weeks after IC)
研究者
Ilona Kulakiene
Professor
Lithuanian University of Health Sciences