NCT01579591Unknown3 期
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
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The impact of the probiotic preparation on increasing the TRG1-2 rate.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The impact of the probiotic preparation on increasing the TRG1-2 rate.
时间窗: From the date of randomization until to the date of surgery, up to 18 weeks
次要结局
- Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity(12-36 months)
- pathological complete response (pCR)(12-36 months)
- impact on reduction of sphincter saving surgery (SSS)(12-36 months)
- disease free survival (DFS) at 36 months(36 months)
- Determine whether VSL#3® can have an impact on reduction of late toxicity at 12 and 36 months.(12, 36 months)
研究者
Vincenzo Valentini
Associated professor
Catholic University of the Sacred Heart
研究点 (2)
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