A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
NCT ID: NCT00385970
Last Updated: 2012-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
380 participants
INTERVENTIONAL
2006-03-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
UFT+LV Group: The group treated with UFT and LV
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
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
2
UFT+PSK Group: The group treated with of UFT and PSK
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
Krestin (PSK)
From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day
Interventions
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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
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
Krestin (PSK)
From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
80 Years
ALL
No
Sponsors
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Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
OTHER
Responsible Party
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Masataka Ikeda, MD, PhD.
Associate Director of Surgery, Osaka National Hospital
Principal Investigators
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Morito Monden, MD, PhD
Role: STUDY_CHAIR
Multicenter Clinical Study Group of Osaka
Locations
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Osaka University Hospital
Suita, Osaka, Japan
Countries
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References
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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.
Other Identifiers
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MCSGO-CCTG-0501
Identifier Type: -
Identifier Source: org_study_id