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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01579591
• Other study ID #: A.1459/2011
• Status: Recruiting
• Phase: Phase 3
• First received: April 12, 2012
• Last updated: April 17, 2012
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: April 2012
• Source: Catholic University of the Sacred Heart
• Contact: Vincenzo Valentini, MD
• Phone: +390630155226
• Email: vvalentini[@]rm.unicatt.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

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

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart- Rome-	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity		12-36 months	Yes
Secondary	pathological complete response (pCR)		12-36 months	Yes
Secondary	impact on reduction of sphincter saving surgery (SSS)		12-36 months	Yes
Secondary	disease free survival (DFS) at 36 months		36 months	Yes
Secondary	Determine whether VSL#3® can have an impact on reduction of late toxicity at 12 and 36 months.		12, 36 months	Yes