None listed
Conditions
Brief summary
Hypopharyngeal carcinoma is a highly malignant and fatal neoplasm and with a poor prognosis. The overall 5-year survival rates for advanced squamous cell carcinoma of the hypopharynx has not changed significantly, despite advances in surgical techniques, chemotherapy, and radiation therapy. Currently pharyngolaryngoesophagectomy followed by irradiation is considered to be the standard treatment for most patients with squamous cell carcinoma of the hypopharynx; however, this traetment strategy is associated with significant morbidity. Neoadjuvant chemotherapy followed by concurrent chemoradiation is an alternative choice for these patients. The current clinical trial aimed to investigate the efficacy and safety of neoadjuvant chemotherapy by TPF regimen followed by concurrent chemoradiation with weekly cisplatin in this regard.
Interventions
single arm phase II study evaluating the efficacy and safety of the combined neoadjuvant chemotherapy with intravenous docetaxel (Taxotere), cisplatin and 5-Fluorouracil (5-FU) [TPF regimen; T: Taxotere, P: Cisplatin F: 5-FU] and concurrent chemoradiation with weekly intravenous cisplatin in patients with squmous cell carcinoma of the hypopharynx
Fifty eligible patients with pathologically proven hypopharyngeal carcinoma are enrolled.
Neoadjuvant chemotherapy: Patients initially receive neoadjuv
single arm phase II study evaluating the efficacy and safety of the combined neoadjuvant chemotherapy with intravenous docetaxel (Taxotere), cisplatin and 5-Fluorouracil (5-FU) [TPF regimen; T: Taxotere, P: Cisplatin F: 5-FU] and concurrent chemoradiation with weekly intravenous cisplatin in patients with squmous cell carcinoma of the hypopharynx Fifty eligible patients with pathologically proven hypopharyngeal carcinoma are enrolled. Neoadjuvant chemotherapy: Patients initially receive neoadjuvant chemotherapy comprising intravenous docetaxel (75 mg/m2) and intravenous cisplatin (100 mg/m2) on day 1 and intravenous 5-FU (750 mg/m2) continuously on days 1-3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses of neoadjuvant chemotherapy, all Patients proceed to chemoradiotherapy. Chemoradiotherapy: 3 weeks after completion of neoadjuvant chemotherapy, patients undergo 7 weeks concurrent chemoradiation with weekly intravenous ciplatin (30 mg/m2). Patients with an incomplete response 4 weeks after completion of treatment proceed to surgery, including pharyngolaryngoesophagectomy.
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 85 Years
Healthy volunteers
No
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,
Outcome results
None listed