N/A
Completed N=882
An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT01696695 ↗Enrolled (actual)
882
Serious AEs
6.2%
Results posted
Nov 2016
Primary outcomePrimary: Median Progression-free Survival (PFS) — 254 Days
Summary
This observational study will evaluate the efficacy and safety of different capecitabine based chemotherapies, alone or in combination with other therapies, as first line treatment of metastatic colorectal cancer in participants during everyday clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression-free Survival (PFS) |
254 | — |
| PRIMARY PFS by Therapeutic Regimens |
194; 391; 242; 392; 240; 392 | — |
| SECONDARY Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1 |
24.3 | — |
| SECONDARY Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1 |
82.9 | — |
| SECONDARY Percentage of Participants Who Underwent Metastasectomy |
6.2 | — |
| SECONDARY Mean Duration of Capecitabine Therapy |
188.8 | — |
| SECONDARY Percentage of Participants With Dose Modification of Capecitabine |
85.6 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with newly diagnosed mCRC who have started first-line capecitabine-based chemotherapy in accordance with the current Hungarian label
Exclusion Criteria
- History of serious or unexpected reaction to fluoropyrimidine therapy
- Hypersensitivity to the active ingredient of Xeloda or to any of the excipients of the product, or to fluorouracil
- Known dihydropyrimidine dehydrogenase deficiency
- Pregnancy or lactation
- Inadequate bone marrow, hepatic or renal function
- Treatment with sorivudine or its chemical analogues (for example, brivudine)
- If any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used
Data sourced from ClinicalTrials.gov (NCT01696695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.