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

NCT ID: NCT01579591

Last Updated: 2012-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VSL#3 PROBIOTIC PREPARATION

Group Type: EXPERIMENTAL

VSL#3

Intervention Type: 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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Vincenzo Valentini

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of Sacred Heart- Rome-

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Vincenzo Valentini, MD

Role: CONTACT

vvalentini@rm.unicatt.it

+390630155226

Facility Contacts

Vincenzo Valentini, MD

Role: primary

vvalentini@rm.unicatt.it

+390630155226

Other Identifiers

A.1459/2011

Identifier Type: -

Identifier Source: org_study_id