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

Primary Purpose

Locally Advanced Head and Neck Carcinoma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

docetaxel, cisplatin, fluorouracil

About this trial

This is an interventional treatment trial for Locally Advanced Head and Neck Carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

biweekly TPF induction

Arm Description

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

Outcomes

Primary Outcome Measures

Response rate after induction chemotherapy

CT and PET scan according to the RECIST 1.1 criteria.

Secondary Outcome Measures

Progression survival

The time from the study registration date to the first day of disease progression at any site

Overall survival

The time from the study registration date to the day of the patients' death.

Adverse event

Record adverse event

Full Information

NCT ID

NCT04397341

First Posted

May 17, 2020

Last Updated

May 17, 2020

Sponsor

China Medical University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04397341

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

March 1, 2014 (Actual)

Primary Completion Date

August 30, 2016 (Actual)

Study Completion Date

September 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Head and Neck Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

biweekly TPF induction

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

docetaxel, cisplatin, fluorouracil

Intervention Description

Biweekly Induction regimen with Docetaxel, Cisplatin and Fluorouracil

Primary Outcome Measure Information:

Title

Response rate after induction chemotherapy

Description

CT and PET scan according to the RECIST 1.1 criteria.

Time Frame

through study completion, an average of 1 years

Secondary Outcome Measure Information:

Title

Progression survival

Description

The time from the study registration date to the first day of disease progression at any site

Time Frame

Through study completion, an average of 6 months

Title

Overall survival

Description

The time from the study registration date to the day of the patients' death.

Time Frame

Through study completion, an average of 6 months

Title

Adverse event

Description

Record adverse event

Time Frame

through study completion, an average of 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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: 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.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32873270

Citation

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.

Results Reference

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

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