Combined neoadjuvant chemotherapy docetaxel (Taxotere), cisplatin and 5-Fluorouracil and concurrent chemoradiation in treating patients with squamous cell carcinoma of the hypopharynx

Phase 2

Active, not recruiting

• Conditions: hypopharyngeal cancer; Cancer - Head and neck

• Registration Number: ACTRN12610000870055
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Pathologically proven hypopharyngeal carcinoma.
2. No prior therapy
3. No clinical or imaging evidence of distant metastasis at the time of study enrollment
4. Karnofsky performance status greater than or equal to 70
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)
Females must not be pregnant or lactating

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)]
6. Patients with severe liver, renal, inflammatory intestinal or blood coagulation disorders,

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response rates determined based on the direct laryngoscopic and physical examination and imaging [(Computed Tomography (CT) scan] findings[Direct laryngoscopic and physical examination and imaging (CT scan) will be performed 3 weeks after the last (3rd) cycle of neoadjuvant chemotherapy and 4 weeks following completion of chemoradiation.]

Secondary Outcome Measures

Name	Time	Method
Acute treatment-related toxicities will be measured by clinician assessment and graded according to the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer(RTOG/EORTC) Late Radiation Morbidity Scoring Schema.[Acute treatment-related toxicites [such as hematologic (leukopenia, anemia, thrombocytopenia), gastrointestinal (diarrhea, vomiting), neurological (neuropathy, pain, hand foot syndrome) toxicities] will be assessed at baseline, at the end of every sequential neoadjuvant chemotherapy cycle and weekly during concurrent chemoradiotherapy.]