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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00385970
Other study ID # MCSGO-CCTG-0501
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received October 8, 2006
Last updated October 25, 2012
Start date March 2006
Est. completion date April 2015

Study information

Verified date October 2012
Source Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 380
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Japan Osaka University Hospital Suita Osaka

Sponsors (1)

Lead Sponsor Collaborator
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 3-Year recurrence-free survival rate 3-years after surgery No
Secondary 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 Yes
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