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

NCT ID: NCT04397341

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-01
• Study Completion Date: 2019-09-15

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.

Conditions

Locally Advanced Head and Neck Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

biweekly TPF induction

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

Group Type: EXPERIMENTAL

docetaxel, cisplatin, fluorouracil

Intervention Type: DRUG

Biweekly Induction regimen with Docetaxel, Cisplatin and Fluorouracil

Interventions

docetaxel, cisplatin, fluorouracil

Biweekly Induction regimen with Docetaxel, Cisplatin and Fluorouracil

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ching Yun Hsieh

Division of Hematology and Oncology, Department of internal medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 32873270 (View on PubMed)

Other Identifiers

CMUH-HO-NPC001

Identifier Type: -

Identifier Source: org_study_id