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

Locally Advanced Head and Neck Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397341
• Other study ID #: CMUH-HO-NPC001
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2014
• Est. completion date: September 15, 2019

Study information

• Verified date: May 2020
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 15, 2019
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Locally Advanced Head and Neck Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• docetaxel, cisplatin, fluorouracil
Biweekly Induction regimen with Docetaxel, Cisplatin and Fluorouracil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate after induction chemotherapy	CT and PET scan according to the RECIST 1.1 criteria.	through study completion, an average of 1 years
Secondary	Progression survival	The time from the study registration date to the first day of disease progression at any site	Through study completion, an average of 6 months
Secondary	Overall survival	The time from the study registration date to the day of the patients' death.	Through study completion, an average of 6 months
Secondary	Adverse event	Record adverse event	through study completion, an average of 6 months