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

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ClinicalTrials.gov Identifier: NCT00497107
Recruitment Status : Unknown
Verified July 2008 by Iwate Medical University.
Recruitment status was:  Recruiting
First Posted : July 6, 2007
Last Update Posted : July 31, 2008
Sponsor:
Information provided by:
Iwate Medical University

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: UFT, Calcium Folinate, PSK Drug: UFT, Calcium Folinate Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2007
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
The Control Group (UFT + Calcium Folinate)
Drug: UFT, Calcium Folinate
Experimental: 2
The PSK Group (UFT + Calcium Folinate + PSK)
Drug: UFT, Calcium Folinate, PSK



Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3-years ]

Secondary Outcome Measures :
  1. Overall survival, compliance, adverse events, QOL, tumor markers [ Time Frame: 3-years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497107


Contacts
Contact: Go Wakabayashi, MD, PhD +81-19-651-5111 gowaka@iwate-med.ac.jp

Locations
Japan
Iwate Medical University Hospital Recruiting
Morioka, Iwate, Japan, 020-8505
Contact: Koki Otsuka, MD    +81-19-651-5111 ext 3627    kokiotsu@iwate-med.ac.jp   
Principal Investigator: Go Wakabayashi, MD, PhD         
Sub-Investigator: Koki Otsuka, MD         
Sponsors and Collaborators
Iwate Medical University
Investigators
Study Director: Go Wakabayashi, MD, PhD Iwate Clinical Oncology Group

Publications:
ClinicalTrials.gov Identifier: NCT00497107     History of Changes
Other Study ID Numbers: ICOG-CC01
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: July 31, 2008
Last Verified: July 2008

Keywords provided by Iwate Medical University:
UFT/LV
PSK
Colorectal cancer
Adjuvant therapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium, Dietary
Levoleucovorin
Leucovorin
Bone Density Conservation Agents
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances