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A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

Phase 3
20 Years
80 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV)
administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with
pTNM stage IIB or III (UICC Sixth version) colorectal cancer/histological curability A
(Japanese Classification of Colorectal Carcinoma, Sixth version) as subjects in a
multicenter collaborative randomized open-label comparative controlled study and
consequently to determine the usefulness of the above regimens as adjuvant therapy after

Inclusion Criteria:

- Patients with pTNM stage IIB or III (UICC Sixth version) primary colon cancer/rectal
cancer who have undergone surgery of histological curability A (including
laparoscopic surgery) (the curability is judged after surgery)

- Patients with primary tumor that directly invades other organs or structures and/or
perforates into the visceral peritoneum (T4) or with histologically positive lymph
node metastasis (N+) (to be judged after surgery)

- Patients who is between 20 and 80 years old at the time of obtaining informed consent

- Patients with performance status of 0 - 2

- Patients without receiving any cancer treatment such as radiation, chemotherapy, and
immunotherapy before surgical operation

- Patients without severe dysfunction of renal, hepatic, or bone marrow function

- Patients without serious complications such as bone marrow suppression, diarrhea, and
infections diseases

- Patients who have given consent to participate in this clinical study by
himself/herself or his/her family

Exclusion Criteria:

- Patients in whom the bottom of tumor reaches the peritoneal reflection

- Patients with lower rectal cancer (Rb), anal canal (P), or circumanal skin (E)

- Patients who has active multiple cancers or whose disease-free survival is less than
5 years even though the cancers are metachronous (except carcinoma in situ and skin

- Women who are currently pregnant or wish to be pregnant during this clinical study

- Patients who are judged to be inappropriate to participate in this clinical study by
the investigator or subinvestigator

Type of Study:


Study Design:

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

Outcome Measure:

3-Year recurrence-free survival rate

Outcome Time Frame:

3-years after surgery

Safety Issue:


Principal Investigator

Morito Monden, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Multicenter Clinical Study Group of Osaka


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

March 2006

Completion Date:

April 2015

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms