AXEL Study: An Observational Study of First-Line Xeloda (Capecitabine) Based Chemotherapy With or Without Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01696695
First received: September 27, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This observational study will evaluate the efficacy and safety of different Xeloda (capecitabine) based chemotherapies, alone or in combination with Avastin (bevacizumab), in first line in patients with metastatic colorectal cancer.
| Condition |
|---|
|
Colorectal Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Program for Assessment of Capecitabine (Xeloda) Based First-line Therapies in Metastatic Colorectal Cancer (AXEL Study) |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival with different Xeloda-based chemotherapy regimens [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response rate (complete response + partial response) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
- Clinical benefit rate (complete response + partial response + stable disease) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
- Metastasectomy rate [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
- Mean duration of Xeloda treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
- Dose modification rate for Xeloda [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with newly diagnosed colorectal cancer who have started first-line capecitabine (Xeloda) based chemotherapy alone or in combination with bevacizumab (Avastin)
Criteria
Inclusion Criteria:
- Patients with newly diagnosed metastatic colorectal cancer who have started first-line Xeloda-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 (e.g. brivudine)
- If any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696695
Contacts
| Contact: Please reference Study ID Number: ML27791 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Hungary | |
| Recruiting | |
| Budapest, Hungary, 1032 | |
| Recruiting | |
| Budapest, Hungary, 1076 | |
| Recruiting | |
| Budapest, Hungary, 1088 | |
| Recruiting | |
| Budapest, Hungary, 1125 | |
| Recruiting | |
| Budapest, Hungary, 1145 | |
| Recruiting | |
| Debrecen, Hungary, 4043 | |
| Recruiting | |
| Gyor, Hungary, 9024 | |
| Recruiting | |
| Gyula, Hungary, 5700 | |
| Recruiting | |
| Kecskemet, Hungary, 6000 | |
| Recruiting | |
| Kistarcsa, Hungary, 2143 | |
| Recruiting | |
| Miskolc, Hungary, 3501 | |
| Recruiting | |
| Nyíregyháza, Hungary, 4400 | |
| Recruiting | |
| Pecs, Hungary, 7624 | |
| Recruiting | |
| Salgótarján, Hungary, 3100 | |
| Recruiting | |
| Szeged, Hungary, 6720 | |
| Recruiting | |
| Szekesfehervar, Hungary, 8000 | |
| Recruiting | |
| Szekszard, Hungary, 7100 | |
| Recruiting | |
| Szentes, Hungary, 6600 | |
| Recruiting | |
| Szombathely, Hungary, 9700 | |
| Recruiting | |
| Tatabanuya, Hungary, 2800 | |
| Recruiting | |
| Veszprem, Hungary, 8200 | |
| Recruiting | |
| Zalaegerszeg, Hungary, 8900 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01696695 History of Changes |
| Other Study ID Numbers: | ML27791 |
| Study First Received: | September 27, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Hungary: National Instutute of Pharmacy |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013