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

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
VSL#3
Placebo
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Catholic University of Sacred Heart- Rome-Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VSL#3 PROBIOTIC PREPARATION

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The impact of the probiotic preparation on increasing the TRG1-2 rate.

Secondary Outcome Measures

Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity
pathological complete response (pCR)
impact on reduction of sphincter saving surgery (SSS)
disease free survival (DFS) at 36 months
Determine whether VSL#3® can have an impact on reduction of late toxicity at 12 and 36 months.

Full Information

First Posted
April 12, 2012
Last Updated
April 17, 2012
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT01579591
Brief Title
VSL#3 Versus Placebo in Increasing the Pathological Major Response Rate in Patients With Rectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VSL#3 PROBIOTIC PREPARATION
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
VSL#3
Intervention Description
1 sachet (4.5x1011 viable lyophilized bacteria)three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 sachet, three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards
Primary Outcome Measure Information:
Title
The impact of the probiotic preparation on increasing the TRG1-2 rate.
Time Frame
From the date of randomization until to the date of surgery, up to 18 weeks
Secondary Outcome Measure Information:
Title
Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity
Time Frame
12-36 months
Title
pathological complete response (pCR)
Time Frame
12-36 months
Title
impact on reduction of sphincter saving surgery (SSS)
Time Frame
12-36 months
Title
disease free survival (DFS) at 36 months
Time Frame
36 months
Title
Determine whether VSL#3® can have an impact on reduction of late toxicity at 12 and 36 months.
Time Frame
12, 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo Valentini, MD
Phone
+390630155226
Email
vvalentini@rm.unicatt.it
Facility Information:
Facility Name
Catholic University of Sacred Heart- Rome-
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Valentini, MD
Phone
+390630155226
Email
vvalentini@rm.unicatt.it
First Name & Middle Initial & Last Name & Degree
Vincenzo Valentini, MD

12. IPD Sharing Statement

Learn more about this trial

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

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