Clinical trial · Interventional
Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery
Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer
- 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, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating colorectal cancer. PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they work compared to observation in treating patients with stage II colorectal 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UFT adjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- UFT adjuvant therapy group
- description
- UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year. During protocol treatment, clinical findings and laboratory values are evaluated every month. After the completion of protocol treatment, patients are followed-up, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.
- interventionNames
- Drug: UFT adjuvant chemotherapy
- type
- NO_INTERVENTION
- label
- Observation group
- description
- Patients are followed-up without adjuvant treatment, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.
Primary outcomes (1)
- measure
- Disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectosigmoid * Stage II disease * Has undergone curative (R0) resection within the past 8 weeks * No suspicion of hereditary colorectal cancer * No severe postoperative complications PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC 3,500-12,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 100 IU/L * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Able to take oral medications * Major organ functions are preserved * No other active malignancy * None of the following conditions: * Uncontrolled diabetes mellitus * Uncontrolled hypertension * Myocardial infarction or unstable angina pectoris within the past 6 months * Liver cirrhosis * Interstitial pneumonia * Pulmonary fibrosis * Severe emphysema * No psychiatric disease or other condition that would preclude study participation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy * No prior or concurrent radiotherapy * No concurrent prophylactic growth factors * No concurrent biologic response modifiers
References
Publications (3)
- DERIVEDUeno H, Ishiguro M, Nakatani E, Ishikawa T, Uetake H, Matsuda C, Nakamoto Y, Kotake M, Kurachi K, Egawa T, Yasumasa K, Murata K, Ikawa O, Shinji S, Murotani K, Matsui S, Teramukai S, Tomita N, Sugihara K; SACURA Study Group. Prospective Multicenter Study on the Prognostic and Predictive Impact of Tumor Budding in Stage II Colon Cancer: Results From the SACURA Trial. J Clin Oncol. 2019 Aug 1;37(22):1886-1894. doi: 10.1200/JCO.18.02059. Epub 2019 Jun 10. PMID 31180819
- DERIVEDMatsuda C, Ishiguro M, Teramukai S, Kajiwara Y, Fujii S, Kinugasa Y, Nakamoto Y, Kotake M, Sakamoto Y, Kurachi K, Maeda A, Komori K, Tomita N, Shimada Y, Takahashi K, Kotake K, Watanabe M, Mochizuki H, Nakagawa Y, Sugihara K; SACURA Study Group. A randomised-controlled trial of 1-year adjuvant chemotherapy with oral tegafur-uracil versus surgery alone in stage II colon cancer: SACURA trial. Eur J Cancer. 2018 Jun;96:54-63. doi: 10.1016/j.ejca.2018.03.009. Epub 2018 Apr 17. PMID 29677641
- DERIVEDIshiguro M, Mochizuki H, Tomita N, Shimada Y, Takahashi K, Kotake K, Watanabe M, Kanemitsu Y, Ueno H, Ishikawa T, Uetake H, Matsui S, Teramukai S, Sugihara K. Study protocol of the SACURA trial: a randomized phase III trial of efficacy and safety of UFT as adjuvant chemotherapy for stage II colon cancer. BMC Cancer. 2012 Jul 7;12:281. doi: 10.1186/1471-2407-12-281. PMID 22769569