EUCTR2013-002466-39-GB进行中（未招募）不适用
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. - NIMRAD (NIMorazole/placebo plus RADiotherapy in head and neck cancer)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 470
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed 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)
- •2. Stage T3/T4 N0; any node +ve case including T1 node +ve; T2N0 base of tongue/hypopharynx
- •3. Patients suitable for definitive radiotherapy. Block dissections may be performed pre-RT for N2/N3 disease
- •4. WHO status 0-2
- •5. Patient fit and able to undergo RT with nimorazole and be expected to complete treatment
- •6. Absence of another disease or previous malignancy which is likely to interfere with the treatment or assessment of response.
- •7. No evidence of distant metastases (M0)
- •8. Unable to tolerate/ unlikely to benefit from platinum chemotherapy or monoclonal antibody therapy
- •9. 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).
- •10. Greater than 18 years of age; no upper age limit
- •11. Available for follow up within the United Kingdom
- •12. Adequate renal and liver function - absolute neutrophil count = 1.5 x 109/L, creatinine = 2 x ULN, platelets > 100 x 109/L, bilirubin = 2 x ULN, AST < 3 x ULN
- •13. The capacity to understand the patient information sheet and the ability to provide written informed consent
- •14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 118
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 352
排除标准
- •1. Patients with T1N0 tumours or those within the nasopharynx, nasal cavity or sinus, oral cavity; T2N0 larynx and tonsil; unknown primary cancer
- •2. Any prior chemotherapy in the last 6 months or RT within the planned radiation field
- •3. Presence of any life threatening illness such as unstable angina or severe chronic obstructive pulmonary disease
- •4. Mental disability or patient otherwise unable to give informed consent and/or complete patient questionnaires
- •5. Hb <100 g/l (patients with anaemia may be transfused to bring Hb levels to >100 g/l.] within 1 week of treatment start)
- •6. Peripheral neuropathy as assessed clinically (CTCAE = Grade 2)
- •7. Use of any investigational drug within 30 days prior to screening
- •8. Severe and/or uncontrolled medical disease
- •9. Any malabsorption syndrome (i.e. partial gastrectomy, small bowel resection, Crohn’s disease or ulcerative colitis)
研究者
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