VSL#3 Versus Placebo in Increasing the Pathological Major Response Rate in Patients With Rectal Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer
• Intervention / Treatment: Other: VSL#3; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Catholic University of Sacred Heart- Rome-

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 1 sachet, three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards
Experimental: VSL#3 PROBIOTIC PREPARATION	Other: VSL#3; 1 sachet (4.5x1011 viable lyophilized bacteria)three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The impact of the probiotic preparation on increasing the TRG1-2 rate.	From the date of randomization until to the date of surgery, up to 18 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: April 17, 2012
• First Posted (Estimate): April 18, 2012

Study Record Updates

• Last Update Posted (Estimate): April 18, 2012
• Last Update Submitted That Met QC Criteria: April 17, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: A.1459/2011