A Study of Neoadjuvant Chemoradiotherapy With 5-FU/Leucovorin (FL) vs. TS-1/Irinotecan in Patients With Locally Advanced Rectal Cancer

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, randomized phase II study. Patients will be randomly assigned to either FL or TS-1/irinotecan preoperative chemotherapy regimens by stratification. Patients in FL group will be treated with bolus injections of 5-FU 400 mg/m2/day and LV 20 mg/m2/day for 3 consecutive days every 4 weeks for 2 cycles, and patients in TS-1/irinotecan will be treated with irinotecan 40 mg/m2/day on days 1, 8, 15, 22, 29. TS-1 at a dose of 35mg/m2 was administered orally twice a day after a meal on the day of irradiation (Monday-Friday) concurrent with radiotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Camptothecin; Irinotecan; Leucovorin

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the rectum

• AJCC/UICC pathologic stages of cT3-4 or cN plus

• Male or female patients, 18 years of age or older

• Be ambulatory and have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• No prior chemotherapy, radiotherapy and immunotherapy

• Adequate major organ functions as following: Hematopoietic function: ANC (absolute neutrophil count)1,500/mm3, Platelet 100,000/mm3, and Hepatic function: serum bilirubin < 1.5 x ULN, AST/ALT levels < 2.5 x ULN, and Renal function: serum creatinine < 1.5 x ULN or Ccr 50 ml/min by Cockcroft formula

• Be willing and able to comply with the protocol for the duration of the study.

• Give written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria:

• Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease

• Patients treated with previous surgery, chemotherapy and/or radiotherapy

• Uncontrolled or severe cardiovascular disease: New York Heart Association class III or IV heart disease, and Unstable angina or myocardial infarction within the past 6 months, and History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality.

• Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.

• Other malignancy within the past 5 years except non-melanomatous skin cancer or carcinoma in situ of the cervix.

• Organ allografts requiring immunosuppressive therapy.

• Psychiatric disorder or uncontrolled seizure that would preclude compliance.

• Pregnant, nursing women or patients with reproductive potential without contraception.

• Patients receiving a concomitant treatment with drugs interacting with 5-FU or irinotecan such as flucytosine, phenytoin, or warfarin et al.

• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency.

• Known hypersensitivity to any of the components of the study medications.

• Received any investigational drug or agent within 4 weeks before beginning treatment with study drug.