Open label, non controlled, non randomized, interventional pilot study to evaluate the response rate after induction therapy with Docetaxel (T) and cisplatin (P) in unresectable locally advanced squamous cell carcinoma of head and neck.
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
- To evaluate the overall response (OR) rate (including CR and partial response (PR)) of subjects treated with induction regimen Docetaxel and cisplatin with locally advanced head and neck cancer.
研究概览
简要总结
Study procedureThis is an interventionalstudy to assess the overall response rate of the patient treated with inductionregimen prior to chemo radiotherapy in patients with locally advanced head andneck cancer. Patients will be treated with induction regimen followed by chemoradiotherapy will be included in the study. The treatment regimen is asfollows:
Induction Regimen:
Patients to receive a 1-hour intravenousinfusion of Docetaxel at 75 mg/m2 followed by a 30-minute intravenous infusionof cisplatin at 75 mg/m2. All patients to be premedicated oral dexamethasone at8 mg twice daily for 3 days, commencing 1 day before Docetaxel infusion.
All patients will be premedicated with Intravenousdexamethasone at 20 mg and either ondansetron or granisetron to be administeredbefore cisplatin infusion.
Cisplatin to be mixed with normal saline andgiven with pretreatment and post treatment intravenous hydration and mannitoldiuresis. Either oral ondansetron 8 mg three times daily for 2 days or oralmetoclopramide 0.5 mg/kg four times daily for 2 days to be given, commencing 16hours after cisplatin. Docetaxel and cisplatin treatments to be repeated every21 days for 3 cycles, provided that the patient’s blood
count had returned to normal (absoluteneutrophil count > 1500/mm3 ; platelet count > 100,000/µl) by the start of thenext scheduled chemotherapy cycle.
CRT:
Intravenous cisplatin to be administered at adose of 30 mg/m2 weekly starting concomitantly with conventional radiotherapyto the primary tumor and to the clinically positive nodes. Intravenouscisplatin to be continued till the radiotherapy continues
Radiotherapy treatment plan:
Planning target volumes(PTVs) of the primary tumor, lymphnode metastases, lymphnodes at risk ofmetastatic disease, critical organs and the major salivary glands will beoutlined on planning CT scan /MRI . Conformal and / or IMRT techniques will beutilized. Gross disease PTV dose will be 66 Gy/30 fractions and sub clinicalPTV dose 60 – 54 Gy/30 fractions. The major salivary glands will be spareaccording to specified criteria.
A boost of 4 – 6 Gy in2-3 fractions to the gross tumor PTV is optional.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •(i)histologically confirmed, unresectable locally advanced SCCHN of oral cavity, oropharynx, larynx or hypopharynx in stage III–IV without evidence of distant metastases (ii)no prior chemotherapy or radiation therapy; (iii)having at least one measurable lesion in one dimension; (iv)age >18 & <65 years with Eastern Cooperative Oncology Group (ECOG) < 1; (v)adequate haematological function with neutrophil count P1500/ml, platelets >100,000/ml and haemoglobin >10 g/ml; (vi)adequate hepatic function with bilirubin <1• the upper normal limit, GOT and GPT 62.5 the upper normal limit and alkaline phosphatase 65 5 times the upper normal limitthe upper normal limit; (vii)renal function within normality with serum creatinine <1.4 mg/dl and creatinine clearance >60 ml/ min calculated by the Cockcroft–Gault method.
排除标准
- •(i)Peripheral neuropathy or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction 6 months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer) (ii)Being treated concomitantly with corticosteroids (except as pre-medication) (iii)Patients having another type of neoplasm.
- •(iv)Previous chemotherapy or radiotherapy (v)Any previous definitive surgery for squamous cell carcinoma of head and neck (vi)Severe weight loss (> 20 % of body weight) in the preceding 3 months.
结局指标
主要结局
To evaluate the overall response (OR) rate (including CR and partial response (PR)) of subjects treated with induction regimen Docetaxel and cisplatin with locally advanced head and neck cancer.
时间窗: Response after Neoadjuvant Chemotherapy
次要结局
- To assess the safety and tolerability of induction regimen Docetaxel and cisplatin in patients with locally advanced head and neck cancer.(safety profile at every cycle)