Clinical trial · Interventional
S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer
Controlled Randomized Trial to Evaluate Efficacy of Adjuvant Chemotherapy Between S-1 and UFT for Locally Advanced Squamous Cell Carcinoma of the Head and Neck: Phase III Study
- 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 S-1 and 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 S-1 or tegafur-uracil after surgery, chemotherapy, biological therapy, and/or radiation therapy may kill any remaining tumor cells. It is not yet known whether S-1 is more effective than tegafur-uracil in treating head and neck cancer. PURPOSE: This randomized phase III trial is studying S-1 to see how well it works compared with tegafur-uracil in treating patients with previously treated stage III or stage IV head and neck cancer.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| tegafur-gimeracil-oteracil potassium | Drug | — | UNRESOLVED |
| tegafur-uracil | Drug | Tegafur | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival
Secondary outcomes (3)
- measure
- Relapse-free survival
- measure
- Overall survival
- measure
- Adverse effects
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) * Stage III or IV disease * Primary tumor in the mesopharynx, hypopharynx, larynx (except T3 N0 tumors of the glottis), oral cavity, or maxillary sinus * Completed definitive treatment for SCCHN within the past 3 months, that included any of the following: * Surgery * Chemotherapy * Biologic therapy * Radiotherapy (e.g., radiotherapy in combination with chemotherapy or pre- or postoperative radiotherapy) * Any other treatment * No clinical evidence of locoregional tumors or distant metastasis within 3 months after the completion of definitive treatment PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC ≥ 3,500/mm\^3 AND ≤ 12,000/mm\^3 * Neutrophil count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * AST and ALT \< 100 IU/L * Bilirubin \< 1.5 mg/dL * Creatinine \< 1.2 mg/dL * No uncontrolled cardiovascular disease * No interstitial pneumonia or pulmonary fibrosis * Must have sufficient oral intake PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent biologic therapy, radiotherapy, other chemotherapy, or any other therapy
References
Publications (1)
- DERIVEDTsukahara K, Kubota A, Hasegawa Y, Takemura H, Terada T, Taguchi T, Nagahara K, Nakatani H, Yoshino K, Higaki Y, Iwae S, Beppu T, Hanamure Y, Tomita K, Kohno N, Kawabata K, Fukushima M, Teramukai S, Fujii M; ACTS-HNC group. Randomized phase III trial of adjuvant chemotherapy with S-1 after curative treatment in patients with squamous-cell carcinoma of the head and neck (ACTS-HNC). PLoS One. 2015 Feb 11;10(2):e0116965. doi: 10.1371/journal.pone.0116965. eCollection 2015. PMID 25671770