Clinical trial · Interventional
A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer
A Phase II Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer
NCT02694718CI-TRIAL-00025436completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the pathological complete tumor response rate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine+Oxaliplatin
- description
- Eligible participants received capecitabine 1000 milligrams per square meter (mg/m\^2) on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Percentage of Participants With Pathological Complete Tumor Response
- timeFrame
- Up to Week 16
- description
- Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.