ACTRN12611000835943
Recruiting
Phase 2
The efficacy and safety of combined neoadjuvant chemotherapy with docetaxel, cisplatin and 5-Fluorouracil (5-FU) [TPF regimen] and concurrent chemoradiation in treating patients with locally advanced nasopharyngeal carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shiraz University of Medical Sciences
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Pathologically proven nasopharyngeal carcinoma.
- •2\. No prior therapy
- •3\. No clinical or imaging evidence of distant metastasis at the time of study enrollment
- •4\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •5\. Written informed consent
- •6\. Normal or acceptable liver, kidney and bone marrow function (Absolute neutrophil count greater than or equal to 1,500/mm3
- •Platelet count greater than or equal to 100,000/mm3
- •Bilirubin \< 1\.5 times the upper limit of the normal range
- •Alkaline phosphatase and transaminases \< 2\.5 times the upper limit of the normal range
- •Serum creatinine \< 1\.7 mg/dL)
Exclusion Criteria
- •1\. Prior therapy 2\. Clinical or imaging evidence of distant metastasis 3\. Patients with a known contraindication (such as allergy to taxan drugs,
- •5\. Patients must have
- •normal cardiac function \[Left ventricular ejection fraction (LVEF) assessed by Multigated radionuclide angiography (MUGA) or echocardiography (ECHO) and clinically satisfactory 12\-lead electrocardiography (ECG)
- •No serious cardiac illness or medical condition within the past 6 months including, but not limited to, any of the following:
- •History of documented congestive heart failure
- •High\-risk uncontrolled arrhythmias
- •Angina pectoris requiring antianginal medication
- •Clinically significant valvular heart disease
- •Evidence of transmural infarction on ECG
- •Poorly controlled hypertension (e.g., systolic blood presure (BP) \> 180 mm Hg or diastolic BP \> 100 mm Hg)]
Outcomes
Primary Outcomes
Not specified
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