NCT00774319Unknown2 期
A Randomised Study of TPF as Neoadjuvant Chemotherapy Followed by Concomitant Chemoradiotherapy (CRT) With Conventional Radiotherapy (RT) Versus Concomitant CRT With Accelerated RT in Patients With Locally Advanced Head and Neck Squamous Cell Cancer (HNSCC) in Good Condition. The Condor Study. A Study of the Dutch Head and Neck Cancer Group (DHNCG).
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- feasibility of both study-arms
研究概览
简要总结
The purpose of this trial is to compare two different treatments for fit patients with head and neck cancer:
All patients are given induction-chemotherapy (docetaxel, cisplatin, 5-FU).
Subsequently patients are being randomised into two groups:
- The first group receives neo-adjuvant chemotherapy ('high' dose cisplatin) and conventional radiotherapy
- The second group receives neo-adjuvant chemotherapy ('low' dose cisplatin) and accelerated radiotherapy.
详细描述
Induction Chemotherapy TPF(arm A and B)
: Docetaxel 75 mg/m2 iv on day 1, Cisplatin 75 mg/ m2 iv on day 1, 5-FU 750 mg/ m2/day iv continuous infusion (in Hickman or port a cath) on days 1-5; prophylactic G-CSF
This cycle will be repeated every 21 days for a maximum of 4 cycles. Clinical evaluation after each cycle and radiological evaluation after 2 cycles will take place. In case of PD or SD (after 2 cycles) with no minor response (no decrease in measurable disease from baseline) concomitant chemoradiotherapy will started per protocol.
Surgery The investigators in each centre can decide neck surgery for residual tumor
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology and staging disease
- •Histologically or cytologically proven non-metastatic locally advanced HNSCC, stage III or IV, for which concomitant chemo-radiotherapy would be the standard therapy
- •Patients can be included either with irresectable disease or for which the concomitant chemoradiotherapy was chosen for organ preservation
- •Measurable disease
- •Primary site: oral cavity, oropharynx, hypopharynx and larynx
- •General conditions
- •Written informed consent
- •Age >18 years and ≤ 65 years
- •WHO performance status 0-1
- •Adequate bone marrow function (WBC > 3.0 x 109/L, platelets > 100 x 109/L, Hb > 6 mmol/L)
- •Adequate hepatic function: total bilirubin <
- •5 x upper normal limit, ASAT and ALAT < 2.5 x upper normal limits
- •Adequate renal function: calculated creatinin clearance > 60ml/min. (Cockcroft-Gault formula) Other
- •Expected adequacy of follow-up.
排除标准
- •General conditions
- •Active alcohol addiction
- •Admission for COPD in the last 12 months
- •Weight loss > 10% in 3 months before entry
- •Pregnancy or lactation
- •Patients (M/F) with reproductive potential not implementing adequate contraceptives measures
- •Prior or current history
- •Prior surgery, radiotherapy or chemotherapy for this tumor
- •Serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or likely to interfere with the study assessments
- •Serious active infections
- •Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin
- •Concomitant treatments
- •Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation
- •Concurrent treatment with any other anti-cancer therapy
结局指标
主要结局
feasibility of both study-arms
时间窗: 2 years
次要结局
- to assess the toxicity profile, tumour response, disease free survival and overall survival in both study-arms. Also QoL will be measured.(2 years)
研究者
研究点 (3)
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