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)

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: Chemotherapy

• Study Type: Observational
• Enrollment (Actual): 882

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1145
    • Fövárosi Önkormányzat uzsoki utcai Kórház
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem, II. Belgyogyaszati Klinika
  • Budapest, Hungary, 1125
    • Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
  • Budapest, Hungary, 1032
    • Szent Margit Hospital
  • Budapest, Hungary, 1076
    • Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
  • Debrecen, Hungary, 4031
    • Kenezy Korhaz Rendelointezet
  • Gyor, Hungary, 9024
    • Petz Aladár Megyei Oktató Kórház
  • Gyula, Hungary, 5700
    • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
  • Kecskemet, Hungary, 6000
    • Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Korhaz; Oncology
  • Miskolc, Hungary, 3501
    • Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
  • Nyíregyháza, Hungary, 4400
    • Josa Andras Korhaz; Dept of Oncoradiology
  • Pecs, Hungary, 7623
    • Pécsi Tudományegyetem Áok; Onkoterapias Intezet
  • Salgótarján, Hungary, 3100
    • Szent Lázár Kórház
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
  • Szekesfehervar, Hungary, 8000
    • Szent Gyorgy Korhaz;Fejer Megyei
  • Szekszard, Hungary, 7100
    • Tolna Megyei Onkormanyzat Balassa Janos Korhaz
  • Szentes, Hungary, 6600
    • Dr. Bugyi Istvan Korhaz
  • Szombathely, Hungary, 9700
    • Vas Megyei Markusovszky Korhaz X; Oncoradiology
  • Tatabanuya, Hungary, 2800
    • Szent Borbala Korhaz
  • Veszprem, Hungary, 8200
    • Veszprem Megyei Csolnoky; Ferenc Korhaz
  • Zalaegerszeg, Hungary, 8900
    • Zala megyei Önkormányzat Kórház és Rendelõintézet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: Capecitabine; First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics; Other Names: Xeloda; Drug: Chemotherapy; First line chemotherapy according to effective official Summary of Product Characteristics. The study protocol does not specify any particular therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1	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.	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	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.	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	Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body.	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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): October 1, 2012

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: ML27791