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

Sponsor
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (Other)
Overall Status
Unknown status
CT.gov ID
NCT00385970
Collaborator
(none)
380
Enrollment
1
Location
2
Arms
109
Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tegafur-uracil (UFT)
  • Drug: Calcium folinate (LV)
  • Drug: Krestin (PSK)
 Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
380 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
Study Start Date :
Mar 1, 2006
Anticipated Primary Completion Date :
Apr 1, 2015
Anticipated Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

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

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

    		•
    Experimental: 2

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

    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: Krestin (PSK)
    From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day
    Other Names:
  • PSK

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 3-Year recurrence-free survival rate [3-years after surgery]

    Secondary Outcome Measures

    1. 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. [5-years after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osaka University Hospital Suita Osaka Japan 565-0871

    Sponsors and Collaborators

    • Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

    Investigators

    • Study Chair: Morito Monden, MD, PhD, Multicenter Clinical Study Group of Osaka

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Masataka Ikeda, MD, PhD., Associate Director of Surgery, Osaka National Hospital, Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
    ClinicalTrials.gov Identifier:
    NCT00385970
    Other Study ID Numbers:
    • MCSGO-CCTG-0501
    First Posted:
    Oct 11, 2006
    Last Update Posted:
    Oct 26, 2012
    Last Verified:
    Oct 1, 2012
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Leucovorin
    polysaccharide-K
    Tegafur
    Calcium
    Levoleucovorin

    Study Results

    No Results Posted as of Oct 26, 2012