Colorectal CancerPhase 4NCT00502671
A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
A Phase 4 study testing capecitabine [Xeloda] in people with Colorectal Cancer, run by Hoffmann-La Roche at 46 sites in Russia.
Trial summary
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). 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 [Xeloda]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 46 sitesRussia
- Study dates
- Jul 2007to Mar 2012
- Phase
- Phase 4
- 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
Who may be able to join
- adult patients, >=18 years of age;
- colon cancer (Dukes stage C);
- surgery, with no evidence of remaining tumor;
- ECOG performance status of <=1.
Who cannot join
- previous therapy for currently treated colon cancer;
- any evidence of metastatic disease;
- history of other malignancy within last 5 years;
- clinically significant cardiac disease.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
Russia46 sites
Study site
Arkhangelsk, 163045
Study site
Astrakhan, 414041
Study site
Barnaul, 656049
Study site
Belgorod, 308010
Study site
Chelyabinsk, 454047
Study site
Irkutsk, 664035
Study site
Izhevsk, 426009
Study site
Kaluga, 248007
Study site
Kazan', 420029
Study site
Kazan', 420111
Study site
Kirov, 610021
Study site
Kostroma, 156005
Study site
Krasnodar, 350040
Study site
Kursk, 305035
Study site
Lipetsk, 398005
Study site
Moscow, 105229
Study site
Moscow, 107005
Study site
Moscow, 119992
Study site
Moscow, 123354
Study site
Moscow, 127006
Study site
Moscow, 143420
Study site
Nizhny Novgorod, 603126
Study site
Novgorod Veliky, 173016
Study site
Obninsk, 249036
Study site
Orenburg, 460021
Study site
Perm, 614 066
Study site
Rostov-on-Don, 344037
Study site
Ryazan, 390011
Study site
Saint Petersburg, 197022
Study site
Saint Petersburg, 197047
Study site
Salekhard, 629001
Study site
Samara, 443031
Study site
Sashi, 354057
Study site
Smolensk, 214000
Study site
Stavropol, 355047
Study site
Surgut, 628408
Study site
Tollyatti, 445846
Study site
Tomsk, 634028
Study site
Tomsk, 634050
Study site
Tver', 170008
Study site
Tyumen, 625047
Study site
Ufa, 450005
Study site
Ufa, 450054
Study site
Volgograd, 400138
Study site
Yekaterinburg, 620905
Study site
Yuzhno-Sakhalinsk, 693010
About this study
Official title: An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C.
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
- Conditions
- Colorectal Cancer
- Being tested
- capecitabine [Xeloda]
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine [Xeloda]Drug
1250mg/m2 po bid on days 1-14 of each 3 week cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: capecitabine [Xeloda] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100.
Measured: Up to 25 weeks (from Baseline to the end of safety follow-up)
Secondary outcomes (1)
Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100.
Measured: Up to 25 weeks (from Baseline to the end of safety follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2012
- Study completionMar 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 228 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
- NCT00502671
- Sponsor's protocol ID
- ML20592
- Status last verified
- Aug 2015
- First submitted
- 17 Jul 2007
- Last updated
- 3 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C.
- ClinicalTrials.gov ID
- NCT00502671
- Acronym / sponsor ID
- ML20592
- Conditions
- Colorectal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Posted 3 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: capecitabine [Xeloda] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, >=18 years of age;
- colon cancer (Dukes stage C);
- surgery, with no evidence of remaining tumor;
- ECOG performance status of <=1.
Key exclusion criteria (4 listed)
- previous therapy for currently treated colon cancer;
- any evidence of metastatic disease;
- history of other malignancy within last 5 years;
- clinically significant cardiac disease.
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 |
|---|---|---|
| capecitabine [Xeloda]1250mg/m2 po bid on days 1-14 of each 3 week cycle | Drug | 1 |
Primary outcome
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
Time frame: Up to 25 weeks (from Baseline to the end of safety follow-up)
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100.
1 secondary outcome
Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE
Time frame: Up to 25 weeks (from Baseline to the end of safety follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
- 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
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing capecitabine [Xeloda] in people with Colorectal Cancer, run by Hoffmann-La Roche at 46 sites in Russia.
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 4 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 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Russia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2015). 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?
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE (time frame: Up to 25 weeks (from Baseline to the end of safety follow-up)). 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 3 Sep 2015.