Biweekly TPF Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of Head and Neck

China Medical University

Status and phase: Completed; Phase 2

Conditions: Locally Advanced Head and Neck Carcinoma

Treatments: Drug: docetaxel, cisplatin, fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT04397341

CMUH-HO-NPC001

Details and patient eligibility

About

This study aimed to assess the efficacy and safety for biweekly TPF as induction chemotherapy for locally advanced head and neck cancer

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

4. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

biweekly TPF induction

Experimental group

Description:

Docetaxel: 50 mg/m2 Cisplatin : 50 mg/m2 5-fluorouracil : 2,500 mg/m2 for 40-48 hrs Leucovorin: 250 mg/m2

Treatment:

Drug: docetaxel, cisplatin, fluorouracil