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Completed

NCT Number: NCT04397341

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

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

Docetaxel, cisplatin, fluorouracil

Drug

Biweekly Induction regimen with Docetaxel, Cisplatin and Fluorouracil

Primary outcomes

  1. Response rate after induction chemotherapy

    Time frame: through study completion, an average of 1 years

    CT and PET scan according to the RECIST 1.1 criteria.

Secondary outcomes

  1. Progression survival

    Time frame: 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

  2. Overall survival

    Time frame: Through study completion, an average of 6 months

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

  3. Adverse event

    Time frame: through study completion, an average of 6 months

    Record adverse event

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
May 21, 2020
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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