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

Phase 2

Completed

• Conditions: Locally Advanced Head and Neck Carcinoma
• Interventions: Drug: docetaxel, cisplatin, fluorouracil

• Registration Number: NCT04397341
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study Start: 2014-03-01
• Primary Completion: 2016-08-30
• Study Completion: 2019-09-15
• Status Verified: 2020-05
• Study First Submitted: 2020-05-17
• Study First Submitted QC: 2020-05-17
• Last Update Submitted: 2020-05-17
• Study First Posted: 2020-05-21
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
biweekly TPF induction	docetaxel, cisplatin, fluorouracil	Docetaxel: 50 mg/m2 Cisplatin : 50 mg/m2 5-fluorouracil : 2,500 mg/m2 for 40-48 hrs Leucovorin: 250 mg/m2

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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