An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)

An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 5 sites in Serbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
How many people: 258 participants
Where: 5 sitesSerbia
Study dates: Jul 2009to Dec 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with metastatic colorectal cancer

Who may be able to join

Adult patients, >/= 18 years of age
Metastatic colorectal cancer
Receiving Xeloda according to registered indication

Who cannot join

Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Serbia5 sites

Study site
Belgrade, 11000
Study site
Belgrade, 11080
Study site
Kamenitz, 21204
Study site
Kragujevac, 34000
Study site
Niš, 18000

Other trials in Serbia

About this study

Official title: Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma

Conditions: Colorectal Cancer
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01697462
Study group	Role	What they receive
Cohort		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.
Measured: Baseline up to end of study (up to 42 months)

Secondary outcomes (3)

Percentage of Participants With Disease Progression
Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.
Measured: Baseline to progressive disease or death (up to 42 months)
Progression-Free Survival (PFS)
PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.
Measured: Baseline to progressive disease or death (up to 42 months)
Number of Participants With Hand-Foot Syndrome (HFS)
HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.
Measured: Baseline up to end of study (up to 42 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Dec 2012

First posted2 Oct 2012 (estimated)
Study startJul 2009
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01697462
Sponsor's protocol ID: ML22585
Status last verified: Nov 2015
First submitted: 28 Sep 2012
Last updated: 26 Jan 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma
ClinicalTrials.gov ID: NCT01697462
Acronym / sponsor ID: ML22585
Conditions: Colorectal Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 2 Oct 2012 (estimated)
Results: Posted 26 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cohort	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with metastatic colorectal cancer

Key inclusion criteria (3 listed)

Adult patients, >/= 18 years of age
Metastatic colorectal cancer
Receiving Xeloda according to registered indication

Key exclusion criteria (1 listed)

Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to end of study (up to 42 months)
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.

3 secondary outcomes

Percentage of Participants With Disease Progression
Time frame: Baseline to progressive disease or death (up to 42 months)
Progression-Free Survival (PFS)
Time frame: Baseline to progressive disease or death (up to 42 months)
Number of Participants With Hand-Foot Syndrome (HFS)
Time frame: Baseline up to end of study (up to 42 months)

Results and safety

Results posted to the registry on 26 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
mCRC Participants	258	181

Primary outcome: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Baseline up to end of study (up to 42 months). Number. Unit: Participants

Measure	mCRC Participants n = 258
Non-Serious AEs	132
SAEs	11

Population analysed: Intent-to-treat (ITT) population included all participants who received at least one dose of the study drug and had a subsequent post baseline assessment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to end of study (up to 42 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
mCRC Participants	11 of 258 (4.3%)	132 of 258 (51.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Colorectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 5 sites in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to end of study (up to 42 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01697462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.