Biweekly TPF Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of Head and Neck
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Drug: docetaxel, cisplatin, fluorouracil
Biweekly Induction regimen with Docetaxel, Cisplatin and Fluorouracil
|
Outcome Measures
Primary Outcome Measures
- Response rate after induction chemotherapy [through study completion, an average of 1 years]
CT and PET scan according to the RECIST 1.1 criteria.
Secondary Outcome Measures
- Progression survival [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
- Overall survival [Through study completion, an average of 6 months]
The time from the study registration date to the day of the patients' death.
- Adverse event [through study completion, an average of 6 months]
Record adverse event
Eligibility Criteria
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.
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The patient has local advanced, and no distant metastatic, and unresectable disease.
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The patient has measurable or valuable disease. 4 Age ≥ 20 years.
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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:
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The patient had previous chemotherapy or radiotherapy for squamous cell carcinoma of head and neck.
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The patient has uncontrolled disorder(s), serious illness or medical condition(s) is/are not be enrolled to study that be confirmed by investigator.
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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.
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Peripheral neuropathy > Grade 2.
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The patient is pregnant or breastfeeding.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- China Medical University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMUH-HO-NPC001