An Observational Study of Continued Bevacizumab Plus Chemotherapy Until First Progression in Participants With Metastatic Colorectal Cancer (CRC)
NCT ID: NCT02305615
Last Updated: 2018-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2015-01-13
2017-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with CRC
This is an observational study; thus, no intervention or treatment is required by the protocol. During the study, the treatment will be determined according to the treating physician decision. Eligible participants will be observed for safety and efficacy of continued bevacizumab plus fluoropyrimidine-based doublet chemotherapy treatment in routine clinical practice for 1 year.
Bevacizumab
Bevacizumab at a dose and schedule according to approved label and SmPC. The recommended dose of bevacizumab, administered as an intravenous infusion, is either 5 milligrams per kilogram (mg/kg) or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks. Bevacizumab is always used in combination with chemotherapy for the treatment of participants with metastatic CRC. It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Chemotherapy
Fluoropyrimidine-based doublet chemotherapy (5-Fluorouracil \[5-FU\] or capecitabine plus oxaliplatin or irinotecan) as first-line treatment; and continued fluoropyrimidine treatment with or without treatment modification for oxaliplatin or irinotecan, as per treating physician discretion.
Interventions
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Bevacizumab
Bevacizumab at a dose and schedule according to approved label and SmPC. The recommended dose of bevacizumab, administered as an intravenous infusion, is either 5 milligrams per kilogram (mg/kg) or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks. Bevacizumab is always used in combination with chemotherapy for the treatment of participants with metastatic CRC. It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Chemotherapy
Fluoropyrimidine-based doublet chemotherapy (5-Fluorouracil \[5-FU\] or capecitabine plus oxaliplatin or irinotecan) as first-line treatment; and continued fluoropyrimidine treatment with or without treatment modification for oxaliplatin or irinotecan, as per treating physician discretion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants having initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to bevacizumab SmPC
* Participants who previously received a minimum 9 cycles of 5-FU-based or a minimum 6 cycles of capecitabine-based induction doublet chemotherapy (i.e. 5-FU or capecitabine + oxaliplatin or irinotecan) plus bevacizumab
* Disease evaluation showed stable disease, partial response, or complete response according to RECIST within one month
Exclusion Criteria
* Participants who received more than 10 cycles of 5-FU-based or more than 7 cycles of capecitabine-based induction doublet chemotherapy plus bevacizumab
* Pregnant or lactating women
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Pécsi Tudományegyetem Áok; Onkoterapias Intezet
Pécs, , Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, , Hungary
Szent Margit Hospital
Budapest, , Hungary
Semmelweis Egyetem Onkologiai Központ
Budapest, , Hungary
Szent Imre Hospital
Budapest, , Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, , Hungary
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
Budapest, , Hungary
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest, , Hungary
Kenezy Korhaz Rendelointezet
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
Gyula, , Hungary
Kaposi Mor Teaching Hospital
Kaposvár, , Hungary
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
Kecskemét, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
Miskolc, , Hungary
Josa Andras Korhaz; Dept of Oncoradiology
Nyíregyháza, , Hungary
Tolna Megyei Onkormanyzat Balassa Janos Korhaz
Szekszárd, , Hungary
Szent Gyorgy Korhaz;Fejer Megyei
Székesfehérvár, , Hungary
Markusovszky Hospital
Szombathely, , Hungary
Szent Borbala Korhaz
Tatabánya, , Hungary
Veszprem Megyei Csolnoky; Ferenc Korhaz
Veszprém, , Hungary
Zala megyei Önkormányzat Kórház és Rendelõintézet
Zalaegerszeg, , Hungary
Countries
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Other Identifiers
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ML29425
Identifier Type: -
Identifier Source: org_study_id
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