Colorectal Cancer
Conditions
Brief summary
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 colorectal cancer 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 surgery.
Detailed description
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 surgery.
Interventions
DRUGTegafur-uracil (UFT)
From within 9 weeks after surgery, 300 mg/m2, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5
DRUGCalcium folinate (LV)
From within 9 weeks after surgery, 75 mg, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5
DRUGKrestin (PSK)
From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day
Sponsors
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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 cancers) * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-Year recurrence-free survival rate | 3-years after surgery |
Secondary
| Measure | Time frame |
|---|---|
| 5-Year survival rate, incidence of adverse events, treatment compliance, QOL, type of metastasis/recurrence, and 3-year and 5-year recurrence-free survival rates and survival rates based on each parameter including colon/rectum, stage, and IAP. | 5-years after surgery |
Countries
Japan
Outcome results
None listed