- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01696695
An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer (AXEL)
17 febbraio 2017 aggiornato da: Hoffmann-La Roche
Program for Assessment of Capecitabine (Xeloda) Based First-line Therapies in Metastatic Colorectal Cancer (AXEL Study)
This observational study will evaluate the efficacy and safety of different capecitabine based chemotherapies, alone or in combination with other therapies, as first line treatment of metastatic colorectal cancer in participants during everyday clinical practice.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Osservativo
Iscrizione (Effettivo)
882
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Budapest, Ungheria, 1145
- Fövárosi Önkormányzat uzsoki utcai Kórház
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Budapest, Ungheria, 1088
- Semmelweis Egyetem, II. Belgyógyászati Klinika
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Budapest, Ungheria, 1125
- Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
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Budapest, Ungheria, 1032
- Szent Margit Hospital
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Budapest, Ungheria, 1076
- Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
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Debrecen, Ungheria, 4031
- Kenezy Korhaz Rendelointezet
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Gyor, Ungheria, 9024
- Petz Aladar Megyei Oktato Korhaz
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Gyula, Ungheria, 5700
- Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
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Kecskemet, Ungheria, 6000
- Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
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Kistarcsa, Ungheria, 2143
- Pest Megyei Flor Korhaz; Oncology
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Miskolc, Ungheria, 3501
- Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
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Nyíregyháza, Ungheria, 4400
- Josa Andras Korhaz; Dept of Oncoradiology
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Pecs, Ungheria, 7623
- Pécsi Tudományegyetem Áok; Onkoterapias Intezet
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Salgótarján, Ungheria, 3100
- Szent Lázár Kórház
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Szeged, Ungheria, 6720
- Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
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Szekesfehervar, Ungheria, 8000
- Szent Gyorgy Korhaz;Fejer Megyei
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Szekszard, Ungheria, 7100
- Tolna Megyei Onkormanyzat Balassa Janos Korhaz
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Szentes, Ungheria, 6600
- Dr. Bugyi Istvan Korhaz
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Szombathely, Ungheria, 9700
- Vas Megyei Markusovszky Korhaz X; Oncoradiology
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Tatabanuya, Ungheria, 2800
- Szent Borbala Korhaz
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Veszprem, Ungheria, 8200
- Veszprem Megyei Csolnoky; Ferenc Korhaz
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Zalaegerszeg, Ungheria, 8900
- Zala megyei Önkormányzat Kórház és Rendelõintézet
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Participants with newly diagnosed colorectal cancer who have started first-line capecitabine based chemotherapy alone or in combination with other therapies.
Descrizione
Inclusion Criteria:
- Participants with newly diagnosed mCRC who have started first-line capecitabine-based chemotherapy in accordance with the current Hungarian label
Exclusion Criteria:
- History of serious or unexpected reaction to fluoropyrimidine therapy
- Hypersensitivity to the active ingredient of Xeloda or to any of the excipients of the product, or to fluorouracil
- Known dihydropyrimidine dehydrogenase deficiency
- Pregnancy or lactation
- Inadequate bone marrow, hepatic or renal function
- Treatment with sorivudine or its chemical analogues (for example, brivudine)
- If any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Metastatic Colorectal Carcinoma (mCRC) Participants
Newly diagnosed mCRC participants, who will receive first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, will be observed.
The choice of therapy is based exclusively on the medical decision of the treating physician before study enrollment.
The study protocol does not enforce treatment initiation and also do not specify any treatment regimen.
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First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics
Altri nomi:
First line chemotherapy according to effective official Summary of Product Characteristics.
The study protocol does not specify any particular therapy.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Median Progression-free Survival (PFS)
Lasso di tempo: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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PFS was assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and is defined as the time from the first dose of indicated treatment to disease progression (PD) or death, whichever occurred first.
Participants who did not progress or died while being followed were censored on the date of the last visit.
Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, which is PFS was assigned a value of 1 day.
PD: at least 20 percent (%) increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm); progression of existing non-target lesions; or presence of new lesions.
Median PFS was estimated using Kaplan-Meier method.
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Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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PFS by Therapeutic Regimens
Lasso di tempo: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first.
Participants who did not progress or died while being followed were censored on the date of the last visit.
PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions.
Median PFS was estimated using Kaplan-Meier method.
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Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1
Lasso di tempo: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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Overall response is defined as a complete response (CR) or a partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart.
Participants were evaluated for tumor response per RECIST v1.1 and assessed by computed tomography (CT) or magnetic resonance imaging (MRI):CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm).
No new lesions.PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions.
The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.
No unequivocal progression of non-target disease.
No new lesions.
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Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1
Lasso di tempo: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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Clinical benefit was defined as having a confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST v1.1.CR: complete disappearance of all target lesions and non-target disease,with the exception of nodal disease.All nodes,both target and non-target, must decrease to normal (short axis <10 mm).No new lesions.PR: >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters while on study.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions,or presence of new lesions.
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Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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Percentage of Participants Who Underwent Metastasectomy
Lasso di tempo: Baseline up to 1254 days
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Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body.
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Baseline up to 1254 days
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Mean Duration of Capecitabine Therapy
Lasso di tempo: Baseline up to 1254 days
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Baseline up to 1254 days
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Percentage of Participants With Dose Modification of Capecitabine
Lasso di tempo: Baseline up to 1254 days
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Baseline up to 1254 days
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 luglio 2011
Completamento primario (Effettivo)
1 dicembre 2014
Completamento dello studio (Effettivo)
1 dicembre 2014
Date di iscrizione allo studio
Primo inviato
27 settembre 2012
Primo inviato che soddisfa i criteri di controllo qualità
27 settembre 2012
Primo Inserito (Stima)
1 ottobre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 marzo 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 febbraio 2017
Ultimo verificato
1 febbraio 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Neoplasie
- Neoplasie per sede
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie gastrointestinali
- Malattie del colon
- Malattie intestinali
- Neoplasie intestinali
- Malattie del retto
- Neoplasie colorettali
- Meccanismi molecolari dell'azione farmacologica
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Capecitabina
Altri numeri di identificazione dello studio
- ML27791
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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