EUCTR2016-000373-21-IT进行中（未招募）1 期
A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy with theIRX-2 Regimen in Patients with Newly Diagnosed Stage II, III or IVA Squamous Cell Carcinoma of the Oral Cavity - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. Pathologically confirmed diagnosis of Stage II, III or IVA squamous cell cancer of the oral cavity (excluding the lip).
- •2. Subjects: males or females at least 18 years of age at study entry.
- •3. Disease is surgically resectable with a curative intent.
- •4. Karnofsky Performance Status = 70%.
- •5. Haematological, Hepatic and Renal functions are adequate for surgical intervention.
- •6. Females of child-bearing potential must have negative urine/serum pregnancy test and agree to used a highly effective form of birth control.
- •7. Subjects are able to give Informed Consent and adhere to the protocol treatment plan.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Prior surgery, radiation or chemotherapy (excluding biopsy or any procedure required for supportive care).
- •2. Tumour of the oropharynx.
- •3. Tumour involvement likely to be associated with T4b cancer.
- •4. Distant metastased (M1 disease).
- •5. Diagnosis of another invasive cancer which is currently not in remission and has required treatment within the last 5 years.
- •6. Known infection with hepatitis B, C or HIV.
- •7. Use of any Investigational agent within 30 days of randomization.
- •8. Symptomatic cardiopulmonary disease which are not clinical stable.
- •9. Myocardial infarction within the last 3 months.
- •10. Stroke or other cerebral vascular insufficiency within last 3 months.
- •11. Daily use systemic immunosuppressive therapy or corticosteroids
- •(except for hormone deficiency) 30 days prior to randomization.
- •12. Known allergies to ciprofloxacin(or other quinolones) acetylsalicylic acid or indomethacin.
研究者
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