Clinical trial · Interventional
Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
A Single Arm, Phase II Study of Neoadjuvant Chemoradiotherapy With Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
- 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)
Statins are widely used as lipid-lowering agents to lower cardiovascular risk with a favorable safety profile. In our recent in vitro study, the addition of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data). So we planned this study to investigate the synergistic effect of simvastatin combined with capecitabine and radiotherapy in locally advanced rectal cancer patients.
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 |
|---|---|---|---|
| Adenocarcinoma of Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Simvastatin
- description
- single arm : Simvastatin
- interventionNames
- Drug: simvastatin
Primary outcomes (1)
- measure
- pathologic complete response rate
- timeFrame
- average of 5 weeks
- description
- pathologic complete response ratewill be shown with 95% confidence intervals
Secondary outcomes (7)
- measure
- rate of sphincter-sparing surgical procedure
- timeFrame
- average of 5 weeks
- description
- rate of sphincter-sparing surgical procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-confirmed adenocarcinoma of rectum * AJCC/UICC clinical stages of cT3-4 or cN+ * age ≥ 20 years * ECOG performance status 0-1 * No prior chemotherapy and radiotherapy * Adequate major organ functions as following: * Written informed consent * Willing and able to comply the protocol Exclusion Criteria: * Prior statins therapy within 1-year from the date of study entry * Uncontrolled or severe cardiovascular disease : New York Heart Association class III or IV heart disease Unstable angina or myocardial infarction within the past 6 months History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality. * Past or current history (within the last 5 years prior to treatment start) of other malignancies except rectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible) * Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection * Pregnant nursing women (women of reproductive potential have to agree to use an effective contraceptive method) * Patients with CPK \> 5 X ULN at baseline * Concomitant use with clarithromycin, erythromycin, itraconazole, ketoconazole, nefazodone, telithromycin, gemfibrozil, cyclosporine, danazol, amiodarone, verapamil
References
Publications (0)
Data not yet available