叶酸补充剂与安慰剂对比用于治疗接受靶向治疗的转移性肾细胞癌患者的粘膜炎不良事件 (DARENCA4)
FASTERCC：叶酸补充剂与安慰剂对比用于治疗接受靶向治疗的转移性肾细胞癌患者的粘膜炎不良事件。来自丹麦肾癌组的随机双盲试验（DARENCA Study-4）
FASTERCC: Folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy. A randomized, double-blind trial from the Danish renal cancer group (DARENCA study-4)
研究概览
详细说明
Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI, immunotherapy or mTOR inhibitor treatment in mRCC patients.
The present trial will assess whether 12 weeks complementary treatment with folic acid in mRCC-patients receiving TKI- or mTOR inhibitor treatment or immunotherapy and displaying CTCAE mucositis grade ≥2 can reduce the degree of mucositis, compared to PLACEBO.
This is a randomized, double-blind, placebo-controlled phase II trial of the effectiveness of folic acid supplement for 12 weeks on mucositis. Both arms will receive best supportive care. No crossover is allowed.
The investigators anticipate a 96-month accrual period. The power calculation indicates a total of 50 patients per group are required.
Block randomization based on received TKI/ mTOR inhibitor/IT-treatment will be performed.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Central Region of Denmark
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Aarhus、Central Region of Denmark、丹麦、8000
- Aarhus University Hospital, Department of oncology
-
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Herlev
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Herlev、Herlev、丹麦、2730
- Department of Oncology, Herlev Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma.
Inclusion Criteria:
- Patients displaying CTCAE ≥2 mucositis during TKI, mTOR inhibitor or immunotherapy treatment.
- Signed written informed consent obtained prior to any study specific procedures.
- Patient must be willing and able to comply with the protocol.
- Age ≥ 18.
- Biopsy proven locally advanced or metastatic renal cell carcinoma.
- Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
- Fertile women of childbearing potential (<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).
- Karnofsky Performance status ≥ 60%.
Exclusion Criteria:
- Known hypersensitivity to folic acid.
- Use of prednisolone more than 10 mg daily.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Treatment arm
5 mg of folic acid (1 tablet) per day for 12 weeks. |
5 mg pr day for 12 weeks |
|
安慰剂比较：Placebo arm
PLACEBO (1 tablet) per day for 12 weeks. |
1 placebo pill pr day for 12 weeks |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CTCAE Mucositis
大体时间：16 weeks
|
The degree of CTCAE mucositis (nasal, oral, pharyngeal, anal, or genital) according to the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE). |
16 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PRO Mucositis frequency
大体时间：16 weeks
|
The frequency of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC. |
16 weeks
|
|
Time to effect on mucositis
大体时间：16 weeks
|
The median time to effect of study drug according to CTCAE 4.0 and PRO. |
16 weeks
|
|
Dose reductions
大体时间：16 weeks
|
The frequency of TKI/mTOR dose reductions in the two groups |
16 weeks
|
|
Treatment discontinuations
大体时间：16 weeks
|
The frequency of TKI/mTOR/immunotherapy treatment discontinuations in the two groups |
16 weeks
|
|
Treatment withdrawals
大体时间：16 weeks
|
The frequency of TKI/mTOR/immunotherapy treatment withdrawals in the two groups |
16 weeks
|
|
GI adverse events degree
大体时间：16 weeks
|
The degree of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO. |
16 weeks
|
|
Hand-foot syndrome degree
大体时间：16 weeks
|
The degree of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO. |
16 weeks
|
|
QOL NCCN
大体时间：16 weeks
|
The quality of life in the two groups according to NCCN-FACT FKSI-19. |
16 weeks
|
|
PRO Mucositis degree
大体时间：16 weeks
|
The degree of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC. |
16 weeks
|
|
GI adverse events frequency
大体时间：16 weeks
|
The frequency of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO. |
16 weeks
|
|
Hand-foot syndrome frequency
大体时间：16 weeks
|
The frequency of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO. |
16 weeks
|
|
QOL MDASI
大体时间：16 weeks
|
The quality of life in the two groups according the M.D. Anderson Symptom Inventory for RCC. |
16 weeks
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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