Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in Normal Clinical Use in the UK Population
11. september 2017 opdateret af: Hoffmann-La Roche
An Observational Study to Investigate the Real World Effectiveness of Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in the UK
This study will focus on participants in the United Kingdom (UK) to collect local data on the effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal cancer in normal clinical use.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Participants with metastatic colorectal cancer
Beskrivelse
Inclusion Criteria:
- Have been diagnosed with metastatic colorectal cancer (mCRC)
- Have a Performance Status (PS) of 0-2, according to the Eastern Cooperative Oncology Group (ECOG) criteria at initiation of bevacizumab treatment
- Be chemotherapy-naive at diagnosis of mCRC or have relapsed more than 12 months after receiving adjuvant chemotherapy for early stage colorectal cancer
- Have received standard fluoropyrimidine-based chemotherapy for first-line treatment of mCRC with or without bevacizumab
- Have sufficient medical records available for assessment of eligibility at the Christie Hospital National Health Service (NHS) Trust, Manchester, United Kingdom
- For Cohort 1 (post CDF funding availability): patients between 2010-2013 who received bevacizumab with first-line chemotherapy
- For Cohort 2 (pre Cancer Drugs Fund [CDF] funding availability): patients propensity matched to cohort 1 between 2005-2008 who did not receive bevacizumab with first-line chemotherapy
Exclusion Criteria:
- Subjects with metastatic colorectal cancer, who have received bevacizumab via a clinical trial
- Subjects with metastatic colorectal cancer, whose medical records are not complete enough to confirm eligibility for the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Cohort 1: bevacizumab
Participants with metastatic colorectal cancer between 2010-2013, who received bevacizumab (25 mg/ml concentrate for solution for infusion) with first-line chemotherapy.
|
Ingen intervention administreret i denne undersøgelse
|
|
Cohort 2: no bevacizumab
Participants with metastatic colorectal cancer between 2005-2008, who did not receive bevacizumab with first-line chemotherapy.
|
Ingen intervention administreret i denne undersøgelse
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Overall Survival (OS)
Tidsramme: From date of metastatic colorectal cancer diagnosis to date of death up to 3 years
|
From date of metastatic colorectal cancer diagnosis to date of death up to 3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Response Rate (RR)
Tidsramme: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
|
From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
|
|
Progression Free Survival (PFS)
Tidsramme: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
|
From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
|
|
Percentage of Participants with Adverse Events of Special Interest
Tidsramme: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
|
From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. september 2015
Primær færdiggørelse (Forventet)
31. december 2015
Studieafslutning (Forventet)
31. december 2015
Datoer for studieregistrering
Først indsendt
2. september 2015
Først indsendt, der opfyldte QC-kriterier
3. september 2015
Først opslået (Skøn)
7. september 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2017
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ML29965
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 .
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