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

Primary Purpose

Colorectal Cancer

Status

Unknown status

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Tegafur-uracil (UFT)

Calcium folinate (LV)

Krestin (PSK)

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Osaka University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

3-Year recurrence-free survival rate

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00385970

First Posted

October 8, 2006

Last Updated

October 25, 2012

Sponsor

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

1. Study Identification

Unique Protocol Identification Number

NCT00385970

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

March 2006 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tegafur-uracil (UFT)

Other Intervention Name(s)

UFT

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Calcium folinate (LV)

Other Intervention Name(s)

Intervention Description

From within 9 weeks after surgery, 75 mg, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5

Intervention Type

Drug

Intervention Name(s)

Krestin (PSK)

Other Intervention Name(s)

PSK

Intervention Description

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

Primary Outcome Measure Information:

Title

3-Year recurrence-free survival rate

Time Frame

3-years after surgery

Secondary Outcome Measure Information:

Title

Time Frame

5-years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morito Monden, MD, PhD

Organizational Affiliation

Multicenter Clinical Study Group of Osaka

Official's Role

Study Chair

Facility Information:

Facility Name

Osaka University Hospital

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

14997197

Citation

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.

Results Reference

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

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