EUCTR2008-005702-39-FR进行中（未招募）1 期
Phase I/II study of Induction Chemotherapy with weekly RAD001, Carboplatine and Paclitaxel in Unresectable or Inoperable Locally Advanced Head and NeckSquamous Cell Carcinoma (HNSCC) - CAPRA
GERCOR0 个研究点目标入组 50 人开始时间: 2009年3月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •inclusion criteria
- •1. Histologically proven squamous cell carcinoma of oral cavity, oropharynx,
- •larynx or hypopharynx
- •2. Unresectable locally advanced disease (T4 N0-N3 of the TNM classification,
- •or resectable with surgery contra-indication).
- •3. Presence of measurable lesions defined as those accurately measured in at
- •least one dimension (longest diameter to be recorded) as > 20 mm with
- •conventional techniques or as > 10 mm with spiral CT scan
- •4. No prior therapy
- •5. Age = 18 years
- •6. WHO performance status = 2
- •7. Life expectancy more than 3 months
- •8. Adequate Hematology laboratory data within 7 days prior to registration
- •Absolute granulocytes> 1.5 x 109/L
- •Platelets > 100 x 109/L
- •Hemoglobin = 9 g/dL
- •9. Adequate Biochemistry laboratory data within 7 days prior to registration
- •Total bilirubin = 1.25 x upper the normal limit
- •Transaminases = 2.5 xUNL
- •Alkaline phosphatases = 5 x UNL
- •Creatinine clearance = 60 mL/min
- •Glycemia = 1.5 x UNL
- •Cholesterolemia = 7.30 mmol/L
- •10. Adequate Hemostasis laboratory data within 7 days prior to registration
- •TP within the normal range
- •11. Capacity to swallow pills
- •12. Women should be post-menopaused or willing to accept the use an effective
- •contraceptive regimen during the treatment period and at least 3 months after
- •the end of the study. All non menopaused women should have a negative
- •pregnancy test within 72 hours prior to registration. Men should accept to use
- •an effective contraception during treatment period and at least 3 months after
- •the end of the study.
- •13. Absence of pre-existing grade = 2 neuropathy
- •14. O2 saturation > 88%
- •15. Signed written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria
- •1. Stade I,II, III, IVc
- •2. Chemotherapy or radiotherapy prior to the study
- •3. Treatment with another investigational drug
- •4. Participation in another therapeutic trial within the 30 days prior to entering this
- •5. Uncontrolled disease such as diabetes, hypertension, symptomatic congestive
- •heart or pulmonary failure, renal or hepatic chronic diseases… (non
- •exhaustive list)
- •6. Uncontrolled severe infectious disease, active hemorrhagic syndrome or anticoagulant
- •7. Past history of cancer except in situ cervix cancer and baso-cellular skin
- •8. Known brain metastases ; cerebral CT scan is not required if no
- •symptomatology is present
- •9. Any psychological, familial, sociological or geographical condition potentially
- •hampering compliance with the study protocol and follow-up schedule; those
- •conditions should be discussed with the patient before registration in the trial
- •10. Concomitant medications: CYP3A4 strong inhibitors : azole antimycotics
- •(itraconazole, ketoconazole) HIV protease inihibitor (ritonavir), erythromycin,
- •anti-epileptic drugs (phenytoin, carbamazepine) (non exhaustive list )
- •11. Pregnancy or lactation
- •12. Eligible for organ preservation program
研究者
相似试验
已完成
1 期
Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.esophageal neoplasmJPRN-UMIN000003370ational Cancer Center Hospital East30
已完成
2 期
The phase II study of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patientsoral squamous cell carcinomaJPRN-UMIN000014632The workshop of chemotherapy for oral cancer55
招募中
1 期
Phase I/II trial of Biweekly induction DCE therapyHead and neck squamous cell carcinomaHead and neck cancer, Squamous cell carcinoma, Induction chemotherapyD000077195JPRN-jRCTs051220137Kiyota Naomi43
已完成
不适用
A Phase I study of induction chemotherapy with S-1 and Cisplatin plus intraperitoneal administration of Docetaxel for gastric cancer with peritoneal disseminatiogastric cancerJPRN-UMIN000002524Department of Surgery Graduate School of Medicine, Kyoto University15
未知
2 期
A Phase II study of induction chemotherapy S-1 and CDDP in patients with FDG-PET positive N2 disease of non-small cell lung cancer.JPRN-C000000358Fukushima Medical University25