Rectal CancerPhase 3NCT01579591
VSL#3 Versus Placebo in Increasing the Pathological Major Response Rate in Patients With Rectal Cancer
A Phase 3 study testing VSL#3 in people with Rectal Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- VSL#3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Catholic University of Sacred Heart- Rome-
Rome, 00168
Vincenzo Valentini, MD, +390630155226, vvalentini@rm.unicatt.it
Vincenzo Valentini, MD
About this study
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
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
- Rectal Cancer
- Being tested
- VSL#3, Placebo
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Other
1 sachet (4.5x1011 viable lyophilized bacteria)three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards.
PlaceboOther
1 sachet, three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards
| Study group | Role | What they receive |
|---|---|---|
| VSL#3 PROBIOTIC PREPARATION | Experimental | Not described Receives: Other: VSL#3 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of the probiotic preparation on increasing the TRG1-2 rate.
Measured: From the date of randomization until to the date of surgery, up to 18 weeks
Secondary outcomes (5)
Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity
Measured: 12-36 months
pathological complete response (pCR)
Measured: 12-36 months
impact on reduction of sphincter saving surgery (SSS)
Measured: 12-36 months
disease free survival (DFS) at 36 months
Measured: 36 months
Determine whether VSL#3® can have an impact on reduction of late toxicity at 12 and 36 months.
Measured: 12, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Valentini, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579591
- Sponsor's protocol ID
- A.1459/2011
- Status last verified
- Apr 2012
- First submitted
- 12 Apr 2012
- Last updated
- 18 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01579591
- Acronym / sponsor ID
- A.1459/2011
- Conditions
- Rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 18 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSL#3 PROBIOTIC PREPARATION | Experimental | Other: VSL#3 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSL#31 sachet (4.5x1011 viable lyophilized bacteria)three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards. | Other | VSL#3 PROBIOTIC PREPARATION |
| Placebo1 sachet, three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards | Other | Placebo |
Primary outcome
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
5 secondary outcomes
Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity
Time frame: 12-36 months
pathological complete response (pCR)
Time frame: 12-36 months
impact on reduction of sphincter saving surgery (SSS)
Time frame: 12-36 months
disease free survival (DFS) at 36 months
Time frame: 36 months
Determine whether VSL#3® can have an impact on reduction of late toxicity at 12 and 36 months.
Time frame: 12, 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VSL#3 in people with Rectal Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Valentini, MD (+390630155226, vvalentini@rm.unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2012.