VSL#3 Versus Placebo in Increasing the Pathological Major Response Rate in Patients With Rectal Cancer
2012年4月17日 更新者:Vincenzo Valentini、Catholic University of the Sacred Heart
A Phase III, Randomized, Double-Blind Placebo Controlled Study of the Probiotic Preparation VSL#3® Versus Placebo in Increasing the Pathological Major Response Rate in Patients Receiving Concurrent Chemotherapy and Pelvic Radiation Therapy
This is a randomized, double-blind, placebo-controlled phase III study involving 160 patients designed to assess the efficacy of the high potency probiotic preparation VSL#3® versus placebo in increasing the pathological major response rate in patients undergoing concurrent CT and pelvic RT.
研究概览
研究类型
介入性
注册 (预期的)
160
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Rome、意大利、00168
- 招聘中
- Catholic University of Sacred Heart- Rome-
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age > 18 years
- Ability to sign informed consent and understand the nature of a placebo- controlled trial.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Life expectancy ≥ 6 months.
- Current diagnosis of cancer that supports the use of continuous definitive or adjuvant external-beam RT to the pelvis to a minimum dose of 4500 cGy delivered with conventional multi-field photon radiotherapy, 3-D conformal photon radiotherapy or intensity modulated photon therapy.
- Will receive concurrent administration of chemotherapy (5-FU, capecitabine, cisplatin, oxaliplatin, carboplatin, and/or mitomycin) during pelvic RT
- The following laboratory values obtained > 28 days prior to registration:
Hemoglobin > 10.0 g/dL WBC > 3,500 Absolute neutrophil count > 1,500 Platelets > 100,000
- ECOG Performance Status (PS) of 0, 1 or 2
- Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment.
Exclusion Criteria:
- Current or prior metastases beyond regional lymph nodes.
- Undergone abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum.
- Known allergy to a probiotic preparation.
Any history of inflammatory bowel disease.
-> grade 3 diarrhea, rectal bleeding, abdominal cramping, or incontinence of stool, ≤7 days prior to registration.
- Any medical condition that may interfere with ability to receive protocol treatment.
- Planned use of leucovorin (because of the risk of secretory diarrhea).
- Split-course RT is planned.
- Prior pelvic RT.
- Proton RT.
- Any of the following:
Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception
- Use of probiotics ≤ 2 weeks prior to registration.
- Use of antibiotics ≤ 1 week prior to registration.
- Planned continuous antibiotic treatment during RT.
- History of gastrointestinal or genitourinary obstruction or porphyria.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:安慰剂
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1 sachet, three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards
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实验性的:VSL#3 PROBIOTIC PREPARATION
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1 sachet (4.5x1011 viable lyophilized bacteria)three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
The impact of the probiotic preparation on increasing the TRG1-2 rate.
大体时间:From the date of randomization until to the date of surgery, up to 18 weeks
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From the date of randomization until to the date of surgery, up to 18 weeks
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次要结果测量
结果测量 |
大体时间 |
---|---|
Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity
大体时间:12-36 months
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12-36 months
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pathological complete response (pCR)
大体时间:12-36 months
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12-36 months
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impact on reduction of sphincter saving surgery (SSS)
大体时间:12-36 months
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12-36 months
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disease free survival (DFS) at 36 months
大体时间:36 months
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36 months
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Determine whether VSL#3® can have an impact on reduction of late toxicity at 12 and 36 months.
大体时间:12, 36 months
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12, 36 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年3月1日
初级完成 (预期的)
2013年3月1日
研究完成 (预期的)
2013年6月1日
研究注册日期
首次提交
2012年4月12日
首先提交符合 QC 标准的
2012年4月17日
首次发布 (估计)
2012年4月18日
研究记录更新
最后更新发布 (估计)
2012年4月18日
上次提交的符合 QC 标准的更新
2012年4月17日
最后验证
2012年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
VSL#3的临床试验
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Dayton Children's HospitalNational Institutes of Health (NIH)终止
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University of Maryland, BaltimoreNational Center for Complementary and Integrative Health (NCCIH)终止
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore...招聘中
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Bambino Gesù Hospital and Research Institute完全的
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Federico II University未知
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Elena Pita CalandreFerring Pharmaceuticals; Actial Farmaceutica S.r.l.完全的