Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments tegafur-uracil (uft), calcium folinate (lv), krestin (psk)
Phase phase 3
Sponsor Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Start date March 2006
End date April 2015
Trial size 380 participants
Trial identifier NCT00385970, MCSGO-CCTG-0501

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
UFT+LV Group: The group treated with UFT and LV
tegafur-uracil (uft) 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
calcium folinate (lv) 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
(Experimental)
UFT+PSK Group: The group treated with of UFT and PSK
tegafur-uracil (uft) 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
krestin (psk) PSK
From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day

Primary Outcomes

Measure
3-Year recurrence-free survival rate
time frame: 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.
time frame: 5-years after surgery

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group.