An observational study in Colorectal Cancer, sponsored by Hoffmann-La Roche. Completed at 9 sites in Slovakia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-07.
Sponsored by Hoffmann-La Roche · Observational
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 74 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with Stage III colon cancer
Exclusion Criteria:
Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
Drug: Capecitabine · Biological: Oxaliplatin
Administered according to the Summary of Product Characteristics.
Also known as: Xeloda
Administered according to the Summary of Product Characteristics.
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).
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
| Milestone | Capecitabine + Oxaliplatin |
|---|---|
| Started | 74 |
| Completed | 9 |
| Not completed | 65 |
| Withdrew: Complete remission | 35 |
| Withdrew: Recurrence | 26 |
| Withdrew: Adverse event | 2 |
| Withdrew: Lost to follow-up | 2 |
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).
| months | Capecitabine + Oxaliplatin |
|---|---|
| Disease-Free Survival (Time to Event) | 25 (15.1 to 34.9) |
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.
| percentage of participants | Capecitabine + Oxaliplatin |
|---|---|
| Safety: Percentage of Participants With Adverse Events | 39.19 |
Collected over Up to 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Capecitabine + Oxaliplatin | — | 1/74 (1.4%) | 23/74 (31.1%) |
| Event | Capecitabine + Oxaliplatin |
|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/74 |
| Event | Capecitabine + Oxaliplatin |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 8/74 |
| DiarrheaGastrointestinal disorders | 8/74 |
| Neuropathy peripheralNervous system disorders | 7/74 |
| NauseaGastrointestinal disorders | 5/74 |
| ParesthesiaNervous system disorders | 4/74 |
| Age, Continuous(years) | Capecitabine + Oxaliplatin |
|---|---|
| Mean | 58.6 ± 10.2 |
| Sex: Female, Male(Participants) | Capecitabine + Oxaliplatin |
|---|---|
| Female | 35 |
| Male | 39 |
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche