NCT01950689已完成3 期
A Randomised Placebo-controlled Trial of Synchronous NIMorazole Versus RADiotherapy Alone in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Not Suitable for Synchronous Chemotherapy or Cetuximab)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 21
- 主要终点
- Locoregional Control in patients with more hypoxic tumours (the enriched population)
研究概览
简要总结
The purpose of this study is to see whether adding Nimorazole to standard radiotherapy benefits patients with locally advanced head and neck squamous cell carcinoma.
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
- Double (Participant, Investigator)
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 (newly diagnosed/ not recurrent) head and neck squamous cell carcinoma; all primary subsites EXCEPT nasal cavity, oral cavity, nasopharynx and paranasal sinus (i.e. oropharynx, hypopharynx, larynx are allowed)
- •Stage T3/T4 N0; any node +ve case including T1 node +ve; T2N0 base of tongue/hypopharynx
- •Patients suitable for definitive radiotherapy. Block dissections may be performed pre-RT for N2/N3 disease
- •WHO status 0-2
- •Patient fit and able to undergo RT with nimorazole and be expected to complete treatment
- •Absence of another disease or previous malignancy which is likely to interfere with the treatment or assessment of response
- •No evidence of distant metastases (M0)
- •Unable to tolerate/unlikely to benefit from platinum chemotherapy or monoclonal antibody therapy
- •Women must be postmenopausal (no menstrual period for a minimum of 1 year) or have a negative serum pregnancy test on entry in the study (even if surgically sterilised) and be using an adequate contraception method. This must be continued for 1 week after completion of nimorazole, unless child bearing potential has been terminated by surgery/radical radiotherapy
- •Men must be willing to use an adequate method of contraception during treatment and until 1 week after nimorazole
- •Greater than 18 years of age; no upper age limit
- •Available for follow up within the United Kingdom
- •Adequate renal and liver function - absolute neutrophil count >=1.5 x 109/L, creatinine <=2x ULN, platelets > 100x109/L, total bilirubin <=2 x ULN, AST or ALT <3 x ULN
- •The capacity to understand the patient information sheet and the ability to provide written informed consent
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
排除标准
- •Patients with T1N0 tumours or those within the nasopharynx, nasal cavity or sinus, oral cavity; T2No larynx and tonsil; unknown primary cancer.
- •Any prior chemotherapy in the last 6 months or RT within the planned radiation field
- •Presence of any life threatening illness such as unstable angina or severe chronic obstructive pulmonary disease
- •Mental disability or patient otherwise unable to give informed consent and/or complete patient questionnaires
- •Hb <100 g/l (patients with anaemia may be transfused to bring Hb levels to >100 g/l within 1 week of treatment start. Please repeat Hb following transfusion to confirm now eligible)
- •Peripheral neurophathy as assessed clinically (CTCAE >=2)
- •Use of any investigational drug within 30 days prior to screening
- •Severe and/or uncontrolled medical disease
- •Any malabsorption syndrome (i.e. partial gastrectomy, small bowel resection, Crohn's disease or ulcerative colitis)
- •Use of Lithium or Phenobarbitone during the study
- •Patients who are breastfeeding or pregnant
- •Previous malignancy within 5 years (except BCC, in-situ Ca e.g. of the cervix)
- •Previous definitive surgery to primary site
研究组 & 干预措施
Nimorazole
Experimental
Nimorazole given in parallel with radiotherapy for 6 weeks
干预措施: Radiotherapy (Radiation)
Placebo
Placebo Comparator
Placebo given in parallel with radiotherapy for 6 weeks.
干预措施: Radiotherapy (Radiation)
Nimorazole
Experimental
Nimorazole given in parallel with radiotherapy for 6 weeks
干预措施: Nimorazole (Drug)
结局指标
主要结局
Locoregional Control in patients with more hypoxic tumours (the enriched population)
时间窗: 12 weeks post treatment
To examine whether patients with locally advanced head and neck squamous cell carcinoma unsuitable for either cisplatin chemotherapy or monoclonal antibody therapy benefit from the addition of nimorazole to standard definitive radiotherapy in terms of increased locoregional control without additional serious toxicity.
次要结局
- Overall survival (enriched sub-group)(Date of death for patient, month 60.)
- Disease-free survival (enriched sub-group)(follow up month 60)
- Cancer-specific survival (enriched sub-group)(follow up month 60)
- Late toxicity (all patients)(baseline, follow up month 6, 12, 18, 24, 36)
- Acute toxicity (all patients)(baseline, week 1, 2, 3, 4, 5, 6, follow up month 1.5 and 3)
- Hypoxia signature prediction of nimorazole benefit (all patients)(screening)
- Cumulative incidence of loco-regional failure(follow up month 60)
- Quality of life (enriched sub-group)(baseline, week 6, month 6, 12, 18, 24, 36 of follow up)
研究者
Yamina Ainaoui
Clinical Trials Manager
The Christie NHS Foundation Trust
研究点 (21)
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