Trial | NCT00385970  Report issue

Official Title

A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    380
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.
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.
Study Started
Mar 31
2006
Primary Completion
Apr 30
2015
Anticipated
Study Completion
Apr 30
2015
Anticipated
Last Update
Oct 26
2012
Estimate

Drug Tegafur-uracil (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

  • Other names: UFT

Drug Calcium folinate (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

  • Other names: LV

Drug Krestin (PSK)

From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day

  • Other names: PSK

1 Active Comparator

UFT+LV Group: The group treated with UFT and LV

2 Experimental

UFT+PSK Group: The group treated with of UFT and PSK

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
No Results Posted