Locally Advanced Head and Neck Carcinoma
Conditions
Brief summary
This study aimed to assess the efficacy and safety for biweekly TPF as induction chemotherapy for locally advanced head and neck cancer
Detailed description
After being informed the study and potential risk, patients was provided written informed consent prior to initiating therapy. The chemotherapy regimen including docetaxel, cisplatin, 5-fluorouracil, and leucovorin was administered every 14 days for six cycles or until disease progression or intolerant treatment toxicity.
Interventions
Biweekly Induction regimen with Docetaxel, Cisplatin and Fluorouracil
Sponsors
China Medical University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate after induction chemotherapy | through study completion, an average of 1 years | CT and PET scan according to the RECIST 1.1 criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression survival | Through study completion, an average of 6 months | The time from the study registration date to the first day of disease progression at any site |
| Overall survival | Through study completion, an average of 6 months | The time from the study registration date to the day of the patients' death. |
| Adverse event | through study completion, an average of 6 months | Record adverse event |
Outcome results
None listed