Colorectal CancerNCT01442155
An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 9 sites in Slovakia.
Trial summary
This observational study evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Capecitabine and Oxaliplatin
- How many people
- 74 participants
- Where
- 9 sitesSlovakia
- Study dates
- Oct 2011to Apr 2015
- 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: Participants with Stage III colon cancer
Who may be able to join
- Adult participants, >/= 18 years of age
- Treatment in line with the currently approved indication in the Summary of Product Characteristics
Who cannot join
- Contraindications according to the current Summary of Product Characteristics
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Slovakia9 sites
Study site
Banská Bystrica, 975 17
Study site
Bratislava, 812 50
Study site
Bratislava, 833 10
Study site
Košice, 04001
Study site
Martin, 036 59
Study site
Nitra, 950 01
Study site
Poprad, 058 01
Study site
Prešov, 081 81
Study site
Ružomberok, 03426
About this study
Official title: An Open Label Study of the Effect of Adjuvant Treatment With Capecitabine in Combination With Oxaliplatin on Disease-Free Survival in Patients With Stage III Colon Cancer
This observational study evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence.
- Conditions
- Colorectal Cancer
- Being tested
- Capecitabine, Oxaliplatin
- Keywords
- Colorectal cancer, Adjuvant setting, Capecitabine, Oxaliplatin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Administered according to the Summary of Product Characteristics.
OxaliplatinBiological
Administered according to the Summary of Product Characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine + Oxaliplatin | Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. Receives: Drug: Capecitabine; Biological: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (Time to Event)
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause).
Measured: Up to 3 years
Secondary outcomes (1)
Safety: Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2015
- Study completionApr 2015
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
- 74 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
- NCT01442155
- Sponsor's protocol ID
- ML25526
- Status last verified
- May 2016
- First submitted
- 26 Sep 2011
- Last updated
- 7 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of the Effect of Adjuvant Treatment With Capecitabine in Combination With Oxaliplatin on Disease-Free Survival in Patients With Stage III Colon Cancer
- ClinicalTrials.gov ID
- NCT01442155
- Acronym / sponsor ID
- ML25526
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Adjuvant setting, Capecitabine, Oxaliplatin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Posted 7 Jul 2016
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 evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine + Oxaliplatin | – | Drug: Capecitabine, Biological: OxaliplatinParticipants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Stage III colon cancer
Key inclusion criteria (2 listed)
- Adult participants, >/= 18 years of age
- Treatment in line with the currently approved indication in the Summary of Product Characteristics
Key exclusion criteria (1 listed)
- Contraindications according to the current 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: XelodaAdministered according to the Summary of Product Characteristics. | Drug | Capecitabine + Oxaliplatin |
| OxaliplatinAdministered according to the Summary of Product Characteristics. | Biological | Capecitabine + Oxaliplatin |
Primary outcome
Disease-Free Survival (Time to Event)
Time frame: Up to 3 years
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause).
1 secondary outcome
Safety: Percentage of Participants With Adverse Events
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
9 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 9 sites in Slovakia.
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 2 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 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Slovakia. 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 7 Jul 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?
Disease-Free Survival (Time to Event) (time frame: Up to 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 7 Jul 2016.