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

NCT01579591 | Unknown Phase 3

• 1 other identifier: A.1459/2011
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

VSL#3 PROBIOTIC PREPARATION

EXPERIMENTAL

Other: VSL#3

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

VSL#3 OTHER

1 sachet (4.5x1011 viable lyophilized bacteria)three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards.

VSL#3 PROBIOTIC PREPARATION

Placebo OTHER

1 sachet, three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart- Rome-

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Vincenzo Valentini, MD

CONTACT

+390630155226; vvalentini@rm.unicatt.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 18, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 18, 2012

Record last verified: 2012-04

Locations

IT (1)