Clinical trial NCT00385970: A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
Official title: A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 380
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3-Year recurrence-free survival rate
timeFrame: 3-years after surgery
Secondary outcomes:
measure: 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.
timeFrame: 5-years after surgery
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Multicenter Clinical Study Group of Osaka
name: Morito Monden, MD, PhD
role: STUDY_CHAIR
References:
citation: Ohwada S, Ikeya T, Yokomori T, Kusaba T, Roppongi T, Takahashi T, Nakamura S, Kakinuma S, Iwazaki S, Ishikawa H, Kawate S, Nakajima T, Morishita Y. Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study. Br J Cancer. 2004 Mar 8;90(5):1003-10. doi: 10.1038/sj.bjc.6601619.