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

NCT04397341 | Completed Phase 2

• 1 other identifier: CMUH-HO-NPC001
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Locally Advanced Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression survival

  Through study completion, an average of 6 months

• Overall survival

  Through study completion, an average of 6 months

• Adverse event

  through study completion, an average of 6 months

Study Arms (1)

biweekly TPF induction

EXPERIMENTAL

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

Drug: docetaxel, cisplatin, fluorouracil

Interventions

docetaxel, cisplatin, fluorouracil DRUG

Biweekly Induction regimen with Docetaxel, Cisplatin and Fluorouracil

biweekly TPF induction

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has histopathologically or cytologically confirmed diagnosis of stage 3 or 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx.
• The patient has local advanced, and no distant metastatic, and unresectable disease.
• The patient has measurable or valuable disease. 4 Age ≥ 20 years.
• \. 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
• 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.

You may not qualify if:

• The patient had previous chemotherapy or radiotherapy for squamous cell carcinoma of head and neck.
• The patient has uncontrolled disorder(s), serious illness or medical condition(s) is/are not be enrolled to study that be confirmed by investigator.
• 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.
• Peripheral neuropathy \> Grade 2.
• The patient is pregnant or breastfeeding.

Sponsors & Collaborators

• China Medical University Hospital: lead

Related Publications (1)

• Hsieh 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 DERIVED

MeSH Terms

Interventions

Docetaxel; Cisplatin; Fluorouracil

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Hematology and Oncology, Department of internal medicine

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: May 21, 2020
• Study Start: March 1, 2014
• Primary Completion: August 30, 2016
• Study Completion: September 15, 2019
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share