Clinical trial · Interventional
Biweekly TPF Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of Head and Neck
A Phase II Study of Biweekly Induction Regimen With Docetaxel, Cisplatin and Fluorouracil for Patients With Locally Advanced Squamous Cell Carcinoma of Head and Neck
NCT04397341CI-TRIAL-00045200completedPhase 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)
This study aimed to assess the efficacy and safety for biweekly TPF as induction chemotherapy for locally advanced 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 |
|---|---|---|---|
| Locally Advanced Head and Neck Carcinoma | Head and Neck Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel, cisplatin, fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- biweekly TPF induction
- description
- Docetaxel: 50 mg/m2 Cisplatin : 50 mg/m2 5-fluorouracil : 2,500 mg/m2 for 40-48 hrs Leucovorin: 250 mg/m2
- interventionNames
- Drug: docetaxel, cisplatin, fluorouracil
Primary outcomes (1)
- measure
- Response rate after induction chemotherapy
- timeFrame
- through study completion, an average of 1 years
- description
- CT and PET scan according to the RECIST 1.1 criteria.
Secondary outcomes (3)
- measure
- Progression survival
- timeFrame
- Through study completion, an average of 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient has histopathologically or cytologically confirmed diagnosis of stage 3 or 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx. 2. The patient has local advanced, and no distant metastatic, and unresectable disease. 3. The patient has measurable or valuable disease. 4 Age ≥ 20 years. 5\. ECOG performance status 0, 1 or 2 at study entry. 6. Life expectancy ≥ 3 months. 7. The patient must have adequate organ function, defined as: 7a Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Hemoglobin * 9.0 g/dL. 7b Total Bilirubin ≤ 1.5 times upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN. 7c Alkaline phosphatase ≤ 2.5 x ULN. 7d Serum creatinine ≤ 1 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m2. 8. Signed informed consent. 9 Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment. Exclusion Criteria: 1. The patient had previous chemotherapy or radiotherapy for squamous cell carcinoma of head and neck. 2. The patient has uncontrolled disorder(s), serious illness or medical condition(s) is/are not be enrolled to study that be confirmed by investigator. 3. Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated and without evidence of recurrence for at least 3 years prior to the study. 4. Peripheral neuropathy \> Grade 2. 5. The patient is pregnant or breastfeeding.
References
Publications (1)
- DERIVEDHsieh CY, Lein MY, Yang SN, Wang YC, Lin YJ, Lin CY, Hua CH, Tsai MH, Lin CC. Dose-dense TPF induction chemotherapy for locally advanced head and neck cancer: a phase II study. BMC Cancer. 2020 Sep 1;20(1):832. doi: 10.1186/s12885-020-07347-6. PMID 32873270