Clinical trial NCT01696695: An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer
Official title: Program for Assessment of Capecitabine (Xeloda) Based First-line Therapies in Metastatic Colorectal Cancer (AXEL Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-01
Enrollment: 882
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with newly diagnosed colorectal cancer who have started first-line capecitabine based chemotherapy alone or in combination with other therapies.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Median Progression-free Survival (PFS)
timeFrame: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
measure: PFS by Therapeutic Regimens
timeFrame: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
Secondary outcomes:
measure: Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1
timeFrame: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
measure: Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1
timeFrame: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
measure: Percentage of Participants Who Underwent Metastasectomy
timeFrame: Baseline up to 1254 days
measure: Mean Duration of Capecitabine Therapy
timeFrame: Baseline up to 1254 days
measure: Percentage of Participants With Dose Modification of Capecitabine
timeFrame: Baseline up to 1254 days
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Szent Margit Hospital
city: Budapest
country: Hungary
facility: Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, II. Belgyógyászati Klinika
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Fövárosi Önkormányzat uzsoki utcai Kórház
city: Debrecen
country: Hungary
facility: Kenezy Korhaz Rendelointezet
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Gyula
country: Hungary
facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Korhaz; Oncology
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
city: Nyíregyháza
country: Hungary
facility: Josa Andras Korhaz; Dept of Oncoradiology
city: Pecs
country: Hungary
facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet
city: Salgótarján
country: Hungary
facility: Szent Lázár Kórház
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
city: Szekesfehervar
country: Hungary
facility: Szent Gyorgy Korhaz;Fejer Megyei
city: Szekszard
country: Hungary
facility: Tolna Megyei Onkormanyzat Balassa Janos Korhaz
city: Szentes
country: Hungary
facility: Dr. Bugyi Istvan Korhaz
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz X; Oncoradiology
city: Tatabanuya
country: Hungary
facility: Szent Borbala Korhaz
city: Veszprem
country: Hungary
facility: Veszprem Megyei Csolnoky; Ferenc Korhaz
city: Zalaegerszeg
country: Hungary
facility: Zala megyei Önkormányzat Kórház és Rendelõintézet
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: