Phase 2
N=62
A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00796718 ↗Enrolled (actual)
62
Serious AEs
6.5%
Results posted
Aug 2016
Primary outcome: Primary: Percentage of Participants With Pathological Complete Response — 16 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Standard radiotherapy (Radiation); Capecitabine [Xeloda] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pathological Complete Response |
16 | — |
| SECONDARY Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment) |
2; 12.2; 77.6 | — |
| SECONDARY Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment) |
56; 10; 14 | — |
| SECONDARY Percentage of Participants With Adverse Events |
91.9 | — |
Summary
This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is < 3 months, and the target sample size is < 100 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, 18-80 years of age;
- rectal cancer;
- planned surgery, and likely to benefit from pre-operative combined chemo-radiotherapy;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria
- previous radiotherapy or chemotherapy for colorectal cancer;
- clinically significant cardiovascular disease;
- significant gastric or small intestine disease;
- serious uncontrolled active infection
Data sourced from ClinicalTrials.gov (NCT00796718). 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.