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

Phase 2
18 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

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

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. Total 45-50.4 Gy radiations in 25-28 fractions to tumor and
draining lymph nodes will be delivered concurrently. Curative surgery (especially total
mesorectal excision will be considered as 1st choice of surgical procedure) will be
performed for about 4-8 weeks after the completion of chemoradiotherapy. Postoperative
chemotherapy regimen is 5-FU plus leucovorin.

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathologic complete response rate

Outcome Description:

To evaluate pathologic complete response rate in patients with resectable rectal cancer teated with neoadjuvant chemoradiotherapy with 5-FU/leucovorin (FL) vs. TS-1/Irinotecan and surgery followed by fluoropyrimidine based adjuvant chemotherapy

Outcome Time Frame:

every 4 weeks in FL group, every 2 weeks in TS-1/irinotecan group

Safety Issue:



South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

October 2008

Completion Date:

February 2017

Related Keywords:

  • Rectal Cancer
  • Rectal Neoplasms