Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
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.
Age
20–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
