Clinical trial · Interventional
Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Head and Neck Cancer
Multicenter Phase II Study of Weekly Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Squamous Cell Cancer of the Head and Neck
NCT01645748CI-TRIAL-00007517TPSHNSCCcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study was to evaluate the tolerability and efficacy of a combination of weekly docetaxel, cisplatin, and S-1 (weekly TPS) as induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1, induction chemotherapy
- description
- Cisplatin and 5-FU is the standard treatment for patients with head and neck cancer. Recently,docetaxel was used into CF, and it showed the prolongation of survival. Oral 5-FU showed similar or enhanced response rate, safety than intravenous 5-FU. S-1 showed promising preliminary result in combination with cisplatin in head and neck cancer. In patients with gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was reported and the recommended doses were 40mg/m2 bid, 60mg/m2 (D1) and 60mg/m2 (D1), respectively. And weekly docetaxel can reduce adverse events compared to 3 week regimen. The aim of this study was to evaluate the efficacy and safety of weekly docetaxel, cisplatin and S-1 combination chemotherapy
- interventionNames
- Drug: S-1
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Response rate was evaluated 1 months after completion of CCRT
- description
- After completion of CCRT, response rate was assessed. Patients underwent examination by an otolaryngologist, CT or MRI imaging of the primary tumor and neck. A biopsy of the primary site was recommended if possible. Tumor response was assessed according to the RECIST. For all patients with complete response (CR) on physical examination and CT or MRI scan, PET scan was performed for confirmation at 1 month after CT or MRI confirmation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * locally advanced stage III or IV squamous cell carcinoma of the larynx, oropharynx, or hypopharynx * ≥18 years old * absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL * serum bilirubin \<2.0 mg/dL * creatinine \<1.5 mg/dL * serum transaminase levels less than twice the upper limit of normal Exclusion Criteria: * received previous chemotherapy * another malignancy * current or history of distant metastasis * history of clinically significant cardiac disease within 6 months * active serious infection * nasopharyngeal carcinoma * psychiatric illness that would preclude obtaining informed consent
References
Publications (1)
- DERIVEDBae WK, Hwang JE, Shim HJ, Cho SH, Lee KH, Han HS, Song EK, Yun HJ, Cho IS, Lee JK, Lim SC, Chung WK, Chung IJ. Multicenter phase II study of weekly docetaxel, cisplatin, and S-1 (TPS) induction chemotherapy for locally advanced squamous cell cancer of the head and neck. BMC Cancer. 2013 Mar 6;13:102. doi: 10.1186/1471-2407-13-102. PMID 23497365