Clinical trial NCT01579591: VSL#3 Versus Placebo in Increasing the Pathological Major Response Rate in Patients With Rectal Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rectal Cancer
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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:
measure: Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity
timeFrame: 12-36 months
measure: pathological complete response (pCR)
timeFrame: 12-36 months
measure: impact on reduction of sphincter saving surgery (SSS)
timeFrame: 12-36 months
measure: disease free survival (DFS) at 36 months
timeFrame: 36 months
measure: Determine whether VSL#3® can have an impact on reduction of late toxicity at 12 and 36 months.
timeFrame: 12, 36 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart- Rome-
Study officials:
References: