Colorectal CancerNCT01276405
An Observational Study of Xeloda (Capecitabine) Monotherapy in Patients With Colorectal Cancer (AXEL)
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 1 site in Romania.
Trial summary
This observational study will evaluate Xeloda (capecitabine) monotherapy on the effect of disease-free survival in patients with colon cancer stage III (Duke C) after surgical resection. Data will be collected for 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 123 participants
- Where
- 1 siteRomania
- Study dates
- Mar 2010to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 colon cancer stage III (Duke C) on Xeloda monotherapy
Who may be able to join
- Adult patients, over the age of 18 years
- Presence of colon adenocarcinoma
- Surgical resection for colon cancer stage III (Duke C)
- Prior adjuvant therapy with Xeloda monotherapy
Who cannot join
- Contraindications for Xeloda
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Adjuvant Chemotherapy With Capecitabine (Xeloda) Monotherapy in Patients With Colon Cancer Stage III (Duke C) Considering the Histopathology of the Tumour (AXEL)
This observational study will evaluate Xeloda (capecitabine) monotherapy on the effect of disease-free survival in patients with colon cancer stage III (Duke C) after surgical resection. Data will be collected for 3 years.
- 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 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.
Disease-free survival
Measured: 3 years
Secondary outcomes (1)
Safety (Incidence of adverse events)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276405
- Sponsor's protocol ID
- ML25174
- Status last verified
- Nov 2016
- First submitted
- 12 Jan 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Adjuvant Chemotherapy With Capecitabine (Xeloda) Monotherapy in Patients With Colon Cancer Stage III (Duke C) Considering the Histopathology of the Tumour (AXEL)
- ClinicalTrials.gov ID
- NCT01276405
- Acronym / sponsor ID
- ML25174
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study will evaluate Xeloda (capecitabine) monotherapy on the effect of disease-free survival in patients with colon cancer stage III (Duke C) after surgical resection. Data will be collected for 3 years.
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 colon cancer stage III (Duke C) on Xeloda monotherapy
Key inclusion criteria (4 listed)
- Adult patients, over the age of 18 years
- Presence of colon adenocarcinoma
- Surgical resection for colon cancer stage III (Duke C)
- Prior adjuvant therapy with Xeloda monotherapy
Key exclusion criteria (1 listed)
- Contraindications for Xeloda
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
Disease-free survival
Time frame: 3 years
1 secondary outcome
Safety (Incidence of adverse events)
Time frame: 3 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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
1 site 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 1 site in Romania.
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 4 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: stopped early, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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?
The study was stopped early. Results are not available in the source record.
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?
Disease-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.