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

NCT00497107 | Unknown Phase 3 DMC

• 1 other identifier: ICOG-CC01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

UFT/LV; PSK; Colorectal cancer; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  3-years

Secondary Outcomes (1)

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

  3-years

Study Arms (2)

1

ACTIVE COMPARATOR

The Control Group (UFT + Calcium Folinate)

Drug: UFT, Calcium Folinate

2

EXPERIMENTAL

The PSK Group (UFT + Calcium Folinate + PSK)

Drug: UFT, Calcium Folinate, PSK

Interventions

UFT, Calcium Folinate, PSK DRUG

2

UFT, Calcium Folinate DRUG

1

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iwate Medical University: lead

Study Sites (1)

Iwate Medical University Hospital

Morioka, Iwate, 020-8505, Japan

RECRUITING

Related Publications (2)

• 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.

  PMID: 14997197 BACKGROUND

• 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.

  PMID: 16648506 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Tegafur; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Go Wakabayashi, MD, PhD

  Iwate Clinical Oncology Group

  STUDY DIRECTOR

Central Study Contacts

Go Wakabayashi, MD, PhD

CONTACT

+81-19-651-5111; gowaka@iwate-med.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 6, 2007
• Study Start: July 1, 2007
• Study Completion: May 1, 2013
• Last Updated: July 31, 2008

Record last verified: 2008-07

Locations

JP (1)