EUCTR2015-005268-41-GR进行中（未招募）1 期
Phase ?? (window) preoperative study of olaparib with or without cisplatin or no treatment in patients with histologically proven squamous cell carcinoma of the head and neck who are candidates for surgery. - OPHELIA
Hellenic Cooperative Oncology Group0 个研究点目标入组 39 人开始时间: 2016年3月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
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
入选标准
- •1.Provision of signed written informed consent prior to any study specific procedures
- •2.Female and/or male patients aged 18 years and over
- •3.Newly diagnosed histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
- •4.Provision of biological material (tumor tissue and blood), provision of signed informed consent for translational research
- •5.Patients selected for a primary surgical treatment
- •6.No prior anti-cancer treatment for head and neck cancer
- •7.Performance status ECOG 0-1
- •8.Adequate hematological status: neutrophils (ANC) =1.5x109/L; platelets =100x109/L; haemoglobin =10g/dL
- •9.Adequate renal function: serum creatinine level 1.5 mg/dl and Glomelular Filtration Rate50 ml/min by Cockroft/Gault formula
- •10.Adequate liver function: serum bilirubin =1.5 x upper normal limit (ULN), alkaline phosphatase, AST, ALT 5xULN
- •11.No active rheumatoid arthritis, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.
- •12.Ability to swallow tablets.
- •13.Regular follow-up feasible
- •14.Baseline evaluations performed before registration: clinical and blood evaluations no more than 1 week (7 days) prior to registration, tumour assessment (CT or MRI scan of the head and neck, chest, abdomen and pelvis at the discretion of the investigator) no more than 30 days prior to registration
- •15.Treatment initiation planned less than 1 week (7 days) after registration
- •16.For female patients of childbearing potential, negative serum pregnancy test within 1 week (7 days) prior of starting study treatment
- •17.Women of childbearing potential and their partners, who are sexually active, must agree to the use of TWO highly effective forms of contraception in combination, throughout the period of taking study treatment and for at least 1-6 month (according to the treatment group) after last dose of study drug(s) (where applicable). Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of TWO highly effective forms of contraception in combination, throughout the period of taking study treatment and for 3-6 months (according tot he treatment group) after last dose of study drug(s) (where applicable).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •1. Metastatic or locally advanced unresectable disease
- •2.Uncontrolled hypercalcemia
- •3.Concomitant unplanned antitumour therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy)
- •4.Treatment with any other investigational medicinal product within 28 days prior to study entry
- •5.Other serious and uncontrolled non-malignant chronic disease
- •6.Treatment with CYP3A4 inhibitors as well as inducers, unless discontinued 7 days prior to randomization
- •7.Any of the following within 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding, treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis
- •8.Other concomitant or previous malignancy, except: i) adequately treated in-situ carcinoma of the uterine cervix, ii) basal or squamous cell carcinoma of the skin, iii) cancer in complete remission for 5 years
- •9.Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days
- •10.Pregnant or breastfeeding women
- •11.Patients with known allergy to any excipients to study drugs
- •12.History of myocardial infarction and/or stroke or other arterial thrombotic events or pulmonary embolism or unstable angina pectoris within 6 months prior to registration
- •13.No features suggestive of MDS/ AML
- •14.Poorly controlled cardiac arrhythmias
- •15.Bowel obstruction
- •16.History of severe tumour bleeding or bleeding disorders
- •17.No blood transfusion within the 28 days prior to study
- •18.Poorly controlled anti-coagulation therapy (INR3.0 on coumadin or heparin compounds)
- •19.Palliative radiation therapy within 4 weeks prior to registration
- •20.Pregnancy or men or women of reproductive age not agreeing to use contraceptive measures
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