Clinical trial · Interventional
Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
A Phase ll Trial of Induction Docetaxel and S-1 Followed by Concomitant Radiotherapy With Low-dose Daily Cisplatin in Locally Advanced Head and Neck 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 docetaxel, S-1, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with radiation therapy and low-dose cisplatin works in treating patients with 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 (4)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate (complete or partial response) as assessed by RECIST criteria
Secondary outcomes (3)
- measure
- Progression-free survival
- measure
- Overall survival
- measure
- Toxicity as assessed by NCI CTCAE v3.0 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Pathologically confirmed head and neck cancer arising from the oral cavity, oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes: * Squamous cell carcinoma * Poorly differentiated carcinoma * Lymphoepithelioma * Locally advanced disease (stage III or IV \[M0\] disease) * At least 1 unidimensionally measurable index lesion PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Bilirubin ≤ 1.5 times the upper limit of normal (ULN) * Alkaline phosphatase ≤ 3.0 times ULN * AST and ALT ≤ 3.0 times ULN * Creatinine ≤ 1.5 times ULN * No concurrent serious systemic disorder that, in the opinion of investigator, would compromise the patient's ability to complete the study * No serious cardiac condition, including any of the following: * Myocardial infarction within the past 6 months * Angina * NYHA class III-IV heart disease * No active infection requiring IV antibiotics, including active tuberculosis or HIV * No other malignancy within the past 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix * Able to comply with protocol or study procedures PRIOR CONCURRENT THERAPY: * No prior radiotherapy or chemotherapy
References
Publications (0)
Data not yet available