N/A
Completed N=51
An Observational Study of Xeloda (Capecitabine) and Oxaliplatin Prior and Concurrent To Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer
Source: ClinicalTrials.gov NCT01339832 ↗Enrolled (actual)
51
Serious AEs
2.0%
Results posted
Feb 2016
Primary outcomePrimary: Progression-free Survival — 15.4 months
Summary
This observational study is a follow-up study of protocol ML18280. Survival data of patients who took part in and concluded study ML18280 will be collected for up to 5 years after LPLV of ML18270.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
15.4 | — |
| SECONDARY Overall Survival |
22.51 | — |
| SECONDARY Tumor Recurrence Rate (Local and Distant) |
16; 4; 12 | — |
| SECONDARY Type of Adjuvant Chemotherapy |
2; 10; 14; 2; 2; 21 | — |
| SECONDARY Length of Adjuvant Chemotherapy |
49.0 | — |
| SECONDARY Compliance to Diagnostic Procedures in Surveillance |
32; 40; 61; 30; 14; 1 | — |
| SECONDARY Long Term Side Effects |
13; 8; 5; 1; 16; 17 | — |
| SECONDARY Incidence of Adverse Event (AE) and Serious Adverse Event (SAE) |
4; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who took part in and concluded study ML18280 according to protocol
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT01339832). 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.