Clinical trial · Interventional
Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
Randomized Phase III Study of UFT+Leucovorin vs. TS-1 as Adjuvant Treatment for Stage III Colon Cancer , and Investigate Predictive Factors Based on Gene Expression
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| folinate calcium | Drug | Immunomodulatory Oligonucleotide | ALIAS |
| tegafur-gimeracil-oteracil potassium | Drug | — | UNRESOLVED |
| tegafur-uracil | Drug | Tegafur | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- tegafur-gimeracil-oteracil potassium
- description
- 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.
- interventionNames
- Drug: tegafur-gimeracil-oteracil potassium
- type
- ACTIVE_COMPARATOR
- label
- tegafur-uracil and folinate calcium
- description
- 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.
- interventionNames
- Drug: folinate calcium
- Drug: tegafur-uracil
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDKusumoto 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
- DERIVEDYoshida 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