NCT01333631Unknown2 期
Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Gemcitabine for Unresectable Locally Advanced Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 主要终点
- Number of the patients with side effects
研究概览
简要总结
This is non-randomized phase 2 study to evaluate toxicity and efficacy of valproic acid (VA) with concurrent chemoradiotherapy (CCRT) containing weekly gemcitabine in patients with unresectable locally advanced pancreatic cancer (ULAPC). All patients will be planned for three-dimensional conformal radiotherapy (3-DCRT). A total dose of 54 Gy will be delivered using 2 Gy daily fractions given over 5 days a week.Intravenous (i.v.) chemotherapy (ChT) with gemcitabine 300 mg/m2 will be started at the first day of 3-DCRT.Total 5-6 weekly doses of i.v. ChT will be planned.VA will be administered orally in daily dose of 800 mg. Treatment with VA will be commenced at the first day and will be terminated at last day of RT.The patients will be followed till disease progression or death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Newly-diagnosed, histologically/cytologically or CA 19.9 confirmed ULAPC
- •No previous RT to abdomen
- •No serious comorbid condition Version 1, December 1, 2010
- •No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry, apart from induction chemotherapy with gemcitabine
- •No participation in clinical trial using any investigational drug or device within four weeks prior to study entry
- •No serious complication of malignant condition
- •No previous or concurrent malignancy at other sites except cone biopsied in situ carcinoma of the uterine cervix and adequately treated basal cell or squamous cell carcinoma of the skin
- •Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
- •Hemoglobin > 9.0 Gm/dL
- •WBC count > 4.0x109/L
- •Neutrophile count > 1.5 cells x 109/L,
- •Platelet count > 100 x 109/L,
- •Creatinine < 1.5 mg/dL
- •Total bilirubin < upper limit of normal (ULN)
- •AST/SGOT < ULN
- •Calcium < ULN
- •Ability to sign informed consent
- •Ability to attend follow-up visits
排除标准
- •Operable disease
- •Distant metastases
- •Previous RT to abdomen
- •Treatment with biological response modifiers or cytotoxic agents other then induction gemcitabine within four weeks prior to study entry
- •Participation in clinical trial using any investigational drug or device within four weeks prior to study entry
- •Major surgical procedure within two weeks prior to study entry
- •Serious comorbid condition, inclusive but not limited to myocardial infarction within previous six months, uncontrolled cardiac arrhythmias, uncontrolled angina pectoris, active infection including acute hepatitis
- •Serious complication of malignant condition
- •Previous or concurrent malignancy
- •Inadequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
- •Hemoglobin < 9.0 Gm/dL
- •WBC count < 4.0x109/L
- •Neutrophile count < 1.5 cells x 109/L,
- •Platelet count < 100 x 109/L,
- •Creatinine > 1.5 mg/dL
- •Total bilirubin > ULN (upper limit of normal)
- •AST/SGOT > ULN
- •Calcium > ULN
- •Inability to sign informed consent
- •Psychological, familial, sociological or geographical conditions which do permit regular medical follow-up and compliance with the protocol.
研究组 & 干预措施
Valporoic acid + chemoradiotherapy
Experimental
干预措施: Valproic acid (Drug)
结局指标
主要结局
Number of the patients with side effects
时间窗: 2 years
次要结局
- Number of the patients survived(2 years)
研究者
相似试验
Unknown
1 期
Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung CancerLocally Advanced Inoperable Non-small-lung CancerNCT01203735Soroka University Medical Center20
已完成
2 期
Valproic Acid and Carnitine in Patients With Spinal Muscular AtrophySpinal Muscular AtrophyNCT00227266University of Utah94
已完成
2 期
PhII 5-Azacytidine Plus Valproic Acid and Eventually Atra in Intermediate II and High Risk MDSMyelodysplastic SyndromesNCT00439673Gruppo Italiano Malattie EMatologiche dell'Adulto62
招募中
2 期
Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal CancerRas-mutated Metastatic Colorectal CancerNCT04310176National Cancer Institute, Naples200
招募中
1 期
Randomized phasE 2 study of Valproic acid in combination with bevacizumab and Oxaliplatin/fLUoropyrimidine regimens in patients with ras-mutated metastaTIc cOlorectal caNcerpatients with ras-mutated metastaTIc colorectal cancerMedDRA version: 20.0Level: LLTClassification code 10007446Term: Carcinoma of rectumSystem Organ Class: 100000004864EUCTR2018-001414-15-ITISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE200