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Uracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer (ICOG)

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
UFT, Calcium Folinate, PSK
UFT, Calcium Folinate
Sponsored by
Iwate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring UFT/LV, PSK, Colorectal cancer, Adjuvant therapy

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with a histological diagnosis of primary colon or rectal cancer (adenocarcinoma)
  • Patient with histological stage IIIa or IIIb cancer (according to the Japanese Classification of Colorectal Cancer, 7th edition)
  • Patient who has undergone curative surgery with no residual cancer
  • Pretreatment criterion: patient who has not undergone preoperative cancer treatment (radiotherapy, chemotherapy or immunotherapy)
  • Patient who is at least 20 years and below 80 years of age
  • Patient with performance status (PS) of 0-1 (according to Eastern Cooperative Oncology Group, ECOG)
  • Restrictions of concomitant medications and therapies: except in the case of metastasis or recurrence, concomitant use of other chemotherapeutic and immunotherapeutic agents that may affect the results of this trial, and concomitant use of radiotherapy are prohibited in principle.
  • Organ function (laboratory data): patient who satisfies the following conditions or data of laboratory tests conducted within 2 weeks prior to start of trial

    • Gastrointestinal function: no diarrhea (watery stool)
    • White blood cell count: > 4,000/mm3
    • Platelet count: > 100,000/mm3
    • Serum GOT and GPT: < 100 IU/L
    • Serum total bilirubin: < 2.0 mg/dL
    • Serum creatinine: below the upper limit of facility normal range

Exclusion Criteria:

  • Patient with residual cancer (R1 or R2)
  • Patient with anal canal lesion (P) or perianal skin lesion (E)
  • Patient with stricture and not capable of oral intake
  • Patient passing fresh blood from the gastrointestinal tract
  • Patient with retention of body cavity fluid necessitating treatment
  • Patient with infection, intestinal palsy or intestinal occlusion
  • Patient with active multiple cancers or patient who has less than 5 years of remission from a metachronous cancer (except carcinoma in situ and skin cancer)
  • Patient who is pregnant or wishes to become pregnant during this trial
  • Patient on continuous insulin treatment for diabetes or has poorly controlled diabetes
  • Patient with a history of ischemic heart disease and judged to have difficulties to participate in this trial
  • Patient with concurrent psychiatric disease or neurological symptoms and judged to have difficulties to participate in this trial
  • Patient on continuous steroid therapy
  • Patient with a history of serious drug allergy
  • Patient who is judged for other reasons by the investigator or doctor in charge to be inappropriate as a subject

Sites / Locations

  • Iwate Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

The Control Group (UFT + Calcium Folinate)

The PSK Group (UFT + Calcium Folinate + PSK)

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

Overall survival, compliance, adverse events, QOL, tumor markers

Full Information

First Posted
July 5, 2007
Last Updated
July 30, 2008
Sponsor
Iwate Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00497107
Brief Title
Uracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer
Acronym
ICOG
Official Title
Phase III Randomized Controlled Clinical Study of UFT/LV Therapy Versus UFT/LV + PSK Therapy as Postoperative Adjuvant Therapy for Histological Stage IIIa and IIIb Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Iwate Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to conduct a randomised controlled trial (RCT) comparing UFT/LV and UFT/LV + PSK in patients with histological stage IIIa/IIIb colorectal cancer who have undergone curative surgery without residual cancer using 3-year disease free survival (DFS) as the primary endpoint, and also to analyze the 3-year overall survival (OS), compliance, adverse events, quality of life (QOL) and relationship with tumor factors.
Detailed Description
To conduct a randomized controlled trial comparing chemotherapy using UFT/LV and immunochemotherapy using UFT/LV combined with PSK in patients with histological stage IIIa and IIIb colorectal cancer (adenocarcinoma) who have undergone curative surgery without residual cancer (R0) using 3-year disease-free survival rate as primary endpoint, and also to analyze the 3-year overall survival, compliance, adverse events, QOL and relationship with tumor factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
UFT/LV, PSK, Colorectal cancer, Adjuvant therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
The Control Group (UFT + Calcium Folinate)
Arm Title
2
Arm Type
Experimental
Arm Description
The PSK Group (UFT + Calcium Folinate + PSK)
Intervention Type
Drug
Intervention Name(s)
UFT, Calcium Folinate, PSK
Intervention Type
Drug
Intervention Name(s)
UFT, Calcium Folinate
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
3-years
Secondary Outcome Measure Information:
Title
Overall survival, compliance, adverse events, QOL, tumor markers
Time Frame
3-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with a histological diagnosis of primary colon or rectal cancer (adenocarcinoma) Patient with histological stage IIIa or IIIb cancer (according to the Japanese Classification of Colorectal Cancer, 7th edition) Patient who has undergone curative surgery with no residual cancer Pretreatment criterion: patient who has not undergone preoperative cancer treatment (radiotherapy, chemotherapy or immunotherapy) Patient who is at least 20 years and below 80 years of age Patient with performance status (PS) of 0-1 (according to Eastern Cooperative Oncology Group, ECOG) Restrictions of concomitant medications and therapies: except in the case of metastasis or recurrence, concomitant use of other chemotherapeutic and immunotherapeutic agents that may affect the results of this trial, and concomitant use of radiotherapy are prohibited in principle. Organ function (laboratory data): patient who satisfies the following conditions or data of laboratory tests conducted within 2 weeks prior to start of trial Gastrointestinal function: no diarrhea (watery stool) White blood cell count: > 4,000/mm3 Platelet count: > 100,000/mm3 Serum GOT and GPT: < 100 IU/L Serum total bilirubin: < 2.0 mg/dL Serum creatinine: below the upper limit of facility normal range Exclusion Criteria: Patient with residual cancer (R1 or R2) Patient with anal canal lesion (P) or perianal skin lesion (E) Patient with stricture and not capable of oral intake Patient passing fresh blood from the gastrointestinal tract Patient with retention of body cavity fluid necessitating treatment Patient with infection, intestinal palsy or intestinal occlusion Patient with active multiple cancers or patient who has less than 5 years of remission from a metachronous cancer (except carcinoma in situ and skin cancer) Patient who is pregnant or wishes to become pregnant during this trial Patient on continuous insulin treatment for diabetes or has poorly controlled diabetes Patient with a history of ischemic heart disease and judged to have difficulties to participate in this trial Patient with concurrent psychiatric disease or neurological symptoms and judged to have difficulties to participate in this trial Patient on continuous steroid therapy Patient with a history of serious drug allergy Patient who is judged for other reasons by the investigator or doctor in charge to be inappropriate as a subject
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Go Wakabayashi, MD, PhD
Phone
+81-19-651-5111
Email
gowaka@iwate-med.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Go Wakabayashi, MD, PhD
Organizational Affiliation
Iwate Clinical Oncology Group
Official's Role
Study Director
Facility Information:
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koki Otsuka, MD
Phone
+81-19-651-5111
Ext
3627
Email
kokiotsu@iwate-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Go Wakabayashi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Koki Otsuka, MD

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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PubMed Identifier
16648506
Citation
Lembersky BC, Wieand HS, Petrelli NJ, O'Connell MJ, Colangelo LH, Smith RE, Seay TE, Giguere JK, Marshall ME, Jacobs AD, Colman LK, Soran A, Yothers G, Wolmark N. Oral uracil and tegafur plus leucovorin compared with intravenous fluorouracil and leucovorin in stage II and III carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project Protocol C-06. J Clin Oncol. 2006 May 1;24(13):2059-64. doi: 10.1200/JCO.2005.04.7498.
Results Reference
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Uracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer

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