Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery

NCT00660894 | Completed Phase 3

• 2 other identifiers: CDR0000593164TMDU-TRICC0706
• Study Type: interventional
• Target: 1,535
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tegafur-uracil together with leucovorin is more effective than giving S-1 in treating patients with stage III colon cancer. PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with leucovorin to see how well it works compared with giving S-1 in treating patients with stage III colon cancer that has been completely removed by surgery.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon; stage III colon cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

Secondary Outcomes (4)

• Overall survival

• Adverse event

• Pharmaco-economics

• Identification of predictive markers

Study Arms (2)

tegafur-gimeracil-oteracil potassium

EXPERIMENTAL

Patients receive tegafur-gimeracil-oteracil potassium(S-1) orally twice daily for 28 days with a subsequent pause of 14 days. This repeats 4 times every 6 weeks.

Drug: tegafur-gimeracil-oteracil potassium

tegafur-uracil and folinate calcium

ACTIVE COMPARATOR

Patients receive tegafur-uracil(UFT) plus folinate calcium(leucovorin) orally every 8 hours for 21 days with a subsequent pause of 7 days. This repeats 5 times every 5 weeks.

Drug: folinate calcium; Drug: tegafur-uracil

Interventions

folinate calcium DRUG

Also known as: Leucovorin, leucovorin

tegafur-uracil and folinate calcium

tegafur-uracil DRUG

Also known as: UFT

tegafur-uracil and folinate calcium

tegafur-gimeracil-oteracil potassium DRUG

Also known as: S-1, TS-1

tegafur-gimeracil-oteracil potassium

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of colon * Stage III (T1-4, N1-3, M0) disease * Has undergone surgical resection of the tumor within the past 8 weeks PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Able to take medications orally * WBC ≥ 3,500/mm³ and \< 12,000/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL * Total bilirubin ≤ 2.0 mg/dL * AST/ALT ≤ 100 IU/L * Creatinine ≤ 1.2 mg/dL * No other active malignancies * Must have none of the following comorbidities: * Severe postoperative complications * Uncontrollable diabetes mellitus * Uncontrollable hypertension * Myocardial infraction within 6 months * Unstable angina pectoris * Hepatocirrhosis * Interstitial pneumonia, pulmonary fibrosis, or severe emphysema PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for colon cancer * No concurrent radiotherapy * No concurrent biological response modifiers

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead

Study Sites (1)

Tokyo Medical and Dental University

Tokyo, Tokyo, 113-8519, Japan

Location

Related Publications (2)

• Kusumoto T, Ishiguro M, Nakatani E, Yoshida M, Inoue T, Nakamoto Y, Shiomi A, Takagane A, Sunami E, Shinozaki H, Takii Y, Maeda A, Ojima H, Hashida H, Mukaiya M, Yokoyama T, Nakamura M, Munemoto Y, Sugihara K. Updated 5-year survival and exploratory T x N subset analyses of ACTS-CC trial: a randomised controlled trial of S-1 versus tegafur-uracil/leucovorin as adjuvant chemotherapy for stage III colon cancer. ESMO Open. 2018 Oct 7;3(6):e000428. doi: 10.1136/esmoopen-2018-000428. eCollection 2018.

  PMID: 30425843 DERIVED

• Yoshida M, Ishiguro M, Ikejiri K, Mochizuki I, Nakamoto Y, Kinugasa Y, Takagane A, Endo T, Shinozaki H, Takii Y, Mochizuki H, Kotake K, Kameoka S, Takahashi K, Watanabe T, Watanabe M, Boku N, Tomita N, Nakatani E, Sugihara K; ACTS-CC study group. S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial). Ann Oncol. 2014 Sep;25(9):1743-1749. doi: 10.1093/annonc/mdu232. Epub 2014 Jun 18.

  PMID: 24942277 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Leucovorin; Tegafur; S 1 (combination); titanium silicide

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)

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

Study Officials

• Kenichi Sugihara, MD, PhD

  Tokyo Medical and Dental University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 17, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2015
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

JP (1)