A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00385970
- Lead Sponsor
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 380
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Calcium folinate (LV) UFT+LV Group: The group treated with UFT and LV 2 Tegafur-uracil (UFT) UFT+PSK Group: The group treated with of UFT and PSK 1 Tegafur-uracil (UFT) UFT+LV Group: The group treated with UFT and LV 2 Krestin (PSK) UFT+PSK Group: The group treated with of UFT and PSK
- Primary Outcome Measures
Name Time Method 3-Year recurrence-free survival rate 3-years after surgery
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Osaka University Hospital
🇯🇵Suita, Osaka, Japan