An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer
AXEL
Program for Assessment of Capecitabine (Xeloda) Based First-line Therapies in Metastatic Colorectal Cancer (AXEL Study)
1 other identifier
observational
882
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 27, 2012
CompletedFirst Posted
Study publicly available on registry
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
November 9, 2016
CompletedMarch 23, 2017
February 1, 2017
3.4 years
September 27, 2012
September 22, 2016
February 17, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Median Progression-free Survival (PFS)
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.
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
PFS by Therapeutic Regimens
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.
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
Secondary Outcomes (5)
Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
Percentage of Participants Who Underwent Metastasectomy
Baseline up to 1254 days
Mean Duration of Capecitabine Therapy
Baseline up to 1254 days
Percentage of Participants With Dose Modification of Capecitabine
Baseline up to 1254 days
Study Arms (1)
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.
Interventions
First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics
First line chemotherapy according to effective official Summary of Product Characteristics. The study protocol does not specify any particular therapy.
Eligibility Criteria
Participants with newly diagnosed colorectal cancer who have started first-line capecitabine based chemotherapy alone or in combination with other therapies.
You may qualify if:
- Participants with newly diagnosed mCRC who have started first-line capecitabine-based chemotherapy in accordance with the current Hungarian label
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Szent Margit Hospital
Budapest, 1032, Hungary
Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
Budapest, 1076, Hungary
Semmelweis Egyetem, II. Belgyógyászati Klinika
Budapest, 1088, Hungary
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
Budapest, 1125, Hungary
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest, 1145, Hungary
Kenezy Korhaz Rendelointezet
Debrecen, 4031, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
Gyula, 5700, Hungary
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
Kecskemét, 6000, Hungary
Pest Megyei Flor Korhaz; Oncology
Kistarcsa, 2143, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
Miskolc, 3501, Hungary
Josa Andras Korhaz; Dept of Oncoradiology
Nyíregyháza, 4400, Hungary
Pécsi Tudományegyetem Áok; Onkoterapias Intezet
Pécs, 7623, Hungary
Szent Lázár Kórház
Salgótarján, 3100, Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, 6720, Hungary
Tolna Megyei Onkormanyzat Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Dr. Bugyi Istvan Korhaz
Szentes, 6600, Hungary
Szent Gyorgy Korhaz;Fejer Megyei
Székesfehérvár, 8000, Hungary
Vas Megyei Markusovszky Korhaz X; Oncoradiology
Szombathely, 9700, Hungary
Szent Borbala Korhaz
Tatabanuya, 2800, Hungary
Veszprem Megyei Csolnoky; Ferenc Korhaz
Veszprém, 8200, Hungary
Zala megyei Önkormányzat Kórház és Rendelõintézet
Zalaegerszeg, 8900, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2012
First Posted
October 1, 2012
Study Start
July 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 23, 2017
Results First Posted
November 9, 2016
Record last verified: 2017-02