A Single Arm, Phase II study of neoadjuvant chemoradiotherapy with capecitabine plus simvastatin in locally advanced rectal cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004037

Enrollment

Registered

2019-06-05

Start date

2014-10-01

Completion date

Unknown

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Capecitabine at a dose of 825mg/m2 was administered orally twice a day and simvastatin at a dose of 80mg once a day on the day of irradiation (Monday-Friday) concurrent with radiotherapy. Total

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Criteria for Inclusion: ? 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: - Hematologic : ANC ? 1500/mm3, platelet?100,000/mm3 - Hepatic : Total bilirubin < 1.5 ULN, AST/ALT <2.5 ? ULN -Renal : Creatinine clearance ? 50 mL/min or serum creatinine < 1.5? ULN ? Written informed consent ? Willing and able to comply the protocol

Exclusion criteria

Exclusion criteria: Criteria for Exclusion: ? Prior statins therapy within 1-year from the date of study entry ? Uncontrolled or severe cardiovascular disease : a) New York Heart Association class III or IV heart disease b) Unstable angina or myocardial infarction within the past 6 months c) 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

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Disease-free Survival;Overall Survival;Patterns of failure;Toxicity	—

Countries

Korea, Republic of

Contacts

Public ContactKang Ki

Samsung Medical Center

wonki.kang@samsung.com+82-2-3410-6820

Outcome results