- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01579591
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
Studieoversigt
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Rome, Italien, 00168
- Rekruttering
- Catholic University of Sacred Heart- Rome-
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
|
1 sachet, three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards
|
Eksperimentel: VSL#3 PROBIOTIC PREPARATION
|
1 sachet (4.5x1011 viable lyophilized bacteria)three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The impact of the probiotic preparation on increasing the TRG1-2 rate.
Tidsramme: From the date of randomization until to the date of surgery, up to 18 weeks
|
From the date of randomization until to the date of surgery, up to 18 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity
Tidsramme: 12-36 months
|
12-36 months
|
pathological complete response (pCR)
Tidsramme: 12-36 months
|
12-36 months
|
impact on reduction of sphincter saving surgery (SSS)
Tidsramme: 12-36 months
|
12-36 months
|
disease free survival (DFS) at 36 months
Tidsramme: 36 months
|
36 months
|
Determine whether VSL#3® can have an impact on reduction of late toxicity at 12 and 36 months.
Tidsramme: 12, 36 months
|
12, 36 months
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A.1459/2011
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Endetarmskræft
-
Institut BergoniéAfsluttetMedium og Lower Rectal CancerFrankrig
-
Fundación de investigación HMSyntax for Science, S.LAfsluttetLocally Advanced Rectal Cancer (LARC)Spanien
-
King Faisal Specialist Hospital & Research CenterAfsluttetColon Rectal Cancer Duke Stage StagevalSaudi Arabien
-
Austrian Breast & Colorectal Cancer Study GroupAfsluttetRectal Cancer Dukes B, Dukes CØstrig
-
University Health Network, TorontoAfsluttet
-
Sir Run Run Shaw HospitalAktiv, ikke rekrutterendeMSS Locally Advanced Rectal AdenocarcinomaKina
-
Sunnybrook Health Sciences CentreUniversity of Toronto; Sunnybrook Research InstituteAfsluttetRectal Neoplasma Carcinoma in Situ AdenocarcinomaCanada
-
Philips HealthcarePhilips Electronics Nederland B.V. acting through Philips CTO organizationAfsluttetMalignt lymfom i lymfeknuder i lyskeregionen | Malignt lymfom af lymfeknuder i aksillært | Malignt lymfom af lymfeknuder i livmoderhalsen | Karcinom i parotidkirtlen | Colon Rectal Cancer Tubulovillous Adenocarcinoma | Tumor af blødt væv i hoved, ansigt og halsHolland
-
Stanford UniversityAfsluttetGastrointestinale neoplasmer | Kræft i bugspytkirtlen | Spiserørskræft | Anal kræft | Hepatobiliær neoplasma | Gastroøsofageal kræft | Galdeblærekarcinom | Leverkarcinom | Galdeblærekræft | Gastrointestinal stromal tumor (GIST) | Karcinom i tyktarmen | Gastrisk (mave) kræft | Galdevejscarcinom | Colon Rectal Cancer AdenocarcinomForenede Stater
Kliniske forsøg med VSL#3
-
Dayton Children's HospitalNational Institutes of Health (NIH)Afsluttet
-
Policlinico HospitalUkendt
-
University of Maryland, BaltimoreNational Center for Complementary and Integrative Health (NCCIH)Afsluttet
-
Bambino Gesù Hospital and Research InstituteAfsluttet
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Rekruttering
-
Policlinico HospitalAfsluttet
-
Beth Israel Deaconess Medical CenterAfsluttet
-
Federico II UniversityUkendt
-
Kaplan-Harzfeld Medical CenterAfsluttetForstoppelse | Diarré
-
Elena Pita CalandreFerring Pharmaceuticals; Actial Farmaceutica S.r.l.AfsluttetFibromyalgi | Gastrointestinal sygdomSpanien