Phase 2
Completed N=60
A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer
Source: ClinicalTrials.gov NCT02694718 ↗Enrolled (actual)
60
Serious AEs
13.3%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants With Pathological Complete Tumor Response — 23 Percentage of participants
Summary
The purpose of this study is to determine the pathological complete tumor response rate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pathological Complete Tumor Response |
23 | — |
| SECONDARY Percentage of Participants With Sphincter-preservation |
84.48 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
7; 7; 16; 8; 9; 1 | — |
| SECONDARY Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer |
100 | — |
| SECONDARY Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes |
47; 48; 65 | — |
| SECONDARY Percentage of Participants With Pathological Incomplete Tumor Response |
72 | — |
| SECONDARY Number of Participants With Any Adverse Events and Serious Adverse Events |
59; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed locally advanced T3/T4 rectal carcinoma with or without nodal involvement requiring surgery of the primary tumor
- Eastern Cooperative Oncology Group performance status 0-2
- Adequate values of laboratory parameters
Exclusion Criteria
- Evidence of distant metastases
- Previous Chemotherapy or immunotherapy for colorectal cancer
- Previous radiotherapy to the pelvis
- Pre-existing condition which would deter radiotherapy
- Malignancy within last 5 years, except cured basal cell cancer of the skin and in situ cancer of the cervix
- Clinically significant cardiac disease or myocardial infarction within the last 12 months
- Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome
- Organ allografts
- Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside analogues
- Dihydropyrimidine dehydrogenase (DPD) deficiency
- History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake
Data sourced from ClinicalTrials.gov (NCT02694718). 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.