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
- Age > 18 years
- Ability to sign informed consent and understand the nature of a placebo- controlled
- 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.
- 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.