- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01339832
An Observational Study of Xeloda (Capecitabine) and Oxaliplatin Prior and Concurrent To Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer
12. April 2017 aktualisiert von: Hoffmann-La Roche
Capecitabine and Oxaliplatin Prior and Concurrent to Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer: A Survival Analysis.
This observational study is a follow-up study of protocol ML18280.
Survival data of patients who took part in and concluded study ML18280 will be collected for up to 5 years after LPLV of ML18270.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
51
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Basel, Schweiz, 4031
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Chur, Schweiz, 7000
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Luzern, Schweiz, 6004
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St. Gallen, Schweiz, 9007
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Zürich, Schweiz, 8063
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Colorectal cancer patients having taken part in study ML18280
Beschreibung
Inclusion Criteria:
- Patients who took part in and concluded study ML18280 according to protocol
Exclusion Criteria:
- N/A
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Kohorte
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Progression-free Survival
Zeitfenster: Up to 5 years
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Progression free survival (PFS) was measured from the date of first administration of study medication in ML18280 study to the date of progression or death, whatever the cause.
In participants with measurable disease, progression was defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0.
Participants with neither tumor recurrence nor death were censored at the last tumor assessment date they were known to have not progressed (last date of diagnostic procedure or diagnostic marker reported in the surveillance).
PFS time in days was calculated as PFS [days]= date of tumor recurrence/death date of first intake + 1, if participant had tumor recurrence confirmed by diagnostic imaging or participant died, then PFS [days] =last diagnostic procedure/marker date- date of first intake+ 1, and if participant survived without tumor recurrence PFS time in months was calculated as PFS [months]= 12 * PFS [days] /365.25
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Up to 5 years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Overall Survival
Zeitfenster: Up to 5 years
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Overall survival (OS) was defined as time from date of first administration of the study medication in ML18280 study to date of death from any cause.
Participants without documented date of death were assumed to be alive and were censored at the latest of the following dates: last date alive on survival status pages, last date known to be alive on survival status pages, and last date of tumor assessment (diagnostic procedures or markers) on surveillance pages.
OS time in days was calculated as OS [days] =date of death date of first intake+ 1, for participants who died, OS [days]= censoring date date of first intake+ 1, for participants alive, and OS time in months was calculated as OS [months]= 12 *OS [days] /365.25
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Up to 5 years
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Tumor Recurrence Rate (Local and Distant)
Zeitfenster: Up to 5 years
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Participant with tumor recurrence were determined by the presence or absence of date of tumor recurrence detection.
In case of absence of empty tumor recurrence date it was considered that the participant had not experienced tumor recurrence.
Participants with local tumor recurrence ('Was it local to the primary tumor?' answered 'yes'.)
compared to participants with distant tumor recurrence (specification for other tumor location given).
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Up to 5 years
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Type of Adjuvant Chemotherapy
Zeitfenster: Up to 5 years
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The type of therapies administered after primary treatments (chemotherapy, surgery or radiation) was reported
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Up to 5 years
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Length of Adjuvant Chemotherapy
Zeitfenster: Up to 5 years
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The length of adjuvant chemotherapy was defined as time between first start date to last stop date of adjuvant chemotherapy regimen.
Length of adjuvant chemotherapy was calculated as length [days] = last stop date - first start date + 1, missing day of start and stop date was replaced by 1.
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Up to 5 years
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Compliance to Diagnostic Procedures in Surveillance
Zeitfenster: Up to 5 years
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The surveillance compliance was calculated per participant in percent and frequencies for methods of diagnostic procedure adhered to, taking into account all expected procedures in the time span the participant participated and was based on the Swiss Society of Gastroenterology (SGG) follow-up care recommendations
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Up to 5 years
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Long Term Side Effects
Zeitfenster: Up to 5 years
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Long term side effects for bowel and urinary function was assessed.
Bowel function was assessed in terms of mean bowel frequency, regular use of constipating agents as well as fecal incontinence.
Urinary function was evaluated according to the presence (YES or NO) of incontinence.
Overall participant satisfaction was assessed in terms of satisfaction with bowel, stoma and urinary function on a 4-stage scale (very good, good, poor, and very poor).
In case of different assessment(s) of bowel or urinary function within the same surveillance period, the assessment with worst grade was documented and reported.
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Up to 5 years
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Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)
Zeitfenster: Up to 5 years
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An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes
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Up to 5 years
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. August 2010
Primärer Abschluss (Tatsächlich)
1. Dezember 2011
Studienabschluss (Tatsächlich)
1. Dezember 2011
Studienanmeldedaten
Zuerst eingereicht
20. April 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. April 2011
Zuerst gepostet (Schätzen)
21. April 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. Mai 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. April 2017
Zuletzt verifiziert
1. April 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ML21875
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