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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00385970
• Other study ID #: MCSGO-CCTG-0501
• 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

• Colorectal Cancer
• Colorectal Neoplasms

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