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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Catholic University of the Sacred Heart.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Vincenzo Valentini, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01579591
First received: April 12, 2012
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Other: VSL#3
Other: Placebo
Phase 3

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

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity [ Time Frame: 12-36 months ] [ Designated as safety issue: Yes ]
  • pathological complete response (pCR) [ Time Frame: 12-36 months ] [ Designated as safety issue: Yes ]
  • impact on reduction of sphincter saving surgery (SSS) [ Time Frame: 12-36 months ] [ Designated as safety issue: Yes ]
  • disease free survival (DFS) at 36 months [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Determine whether VSL#3® can have an impact on reduction of late toxicity at 12 and 36 months. [ Time Frame: 12, 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Placebo Comparator: Placebo Other: Placebo
1 sachet, three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579591

Contacts
Contact: Vincenzo Valentini, MD +390630155226 vvalentini@rm.unicatt.it

Locations
Italy
Catholic University of Sacred Heart- Rome- Recruiting
Rome, Italy, 00168
Contact: Vincenzo Valentini, MD    +390630155226    vvalentini@rm.unicatt.it   
Principal Investigator: Vincenzo Valentini, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

No publications provided

Responsible Party: Vincenzo Valentini, Associated professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01579591     History of Changes
Other Study ID Numbers: A.1459/2011
Study First Received: April 12, 2012
Last Updated: April 17, 2012
Health Authority: Italy: Ethics Committee

ClinicalTrials.gov processed this record on October 19, 2014