A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
This trial is active, not recruiting.
|Treatments||tegafur-uracil (uft), calcium folinate (lv), krestin (psk)|
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
3-Year recurrence-free survival rate
time frame: 3-years after surgery
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
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
|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.|
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