Clinical trial · Interventional
VSL#3 Versus Placebo in Increasing the Pathological Major Response Rate in Patients With Rectal Cancer
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
NCT01579591CI-TRIAL-00006731unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| VSL#3 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VSL#3 PROBIOTIC PREPARATION
- interventionNames
- Other: VSL#3
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- The impact of the probiotic preparation on increasing the TRG1-2 rate.
- timeFrame
- From the date of randomization until to the date of surgery, up to 18 weeks
Secondary outcomes (5)
- measure
- Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.