hypopharyngeal carcinoma
Conditions
Interventions
Group 1:hypofractionated IMRT
Group 2:conventional fractionated IMRT
Sponsors
Department of oncology Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. histologically proven malignant tumor of hypopharynx; stage III-IVb; 2. Life expectancy 3 months or longer; 3. KPS score =70; 4. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 7 days prior to randomization: Hemoglobin = 100g/L, ANC = 1.5*10^9/L without granulocyte colony-stimulating factor support, Platelet count =100*10^9/L; Serum bilirubin = 1.5×ULN, AST, ALT = 1.5×ULN; Serum creatinine = 1.5 × ULN or eGFR =60ml/min, urea nitrogen =200mg/L; 5. Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 7 days prior to initiation of study. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception and to continue its use for 180 days after the last radiation; 6. Signed Informed Consent Form; 7. Comply with research plan and follow-up process; 8. Male or female aged 18 to 75 years.
Exclusion criteria
Exclusion criteria: 1. Prior conventional radiotherapy for hypopharyn carcinoma; 2. Treatment with any other investigational agent or participation in another clinical trial; 3. Malignancies other than hypopharyn carcinoma within 5 years prior to randomization; 4. History of any systemic diseases including: active infections, uncontrolled hypertension, congestive heart-failure, myocardial infarction, severe arrhythmia, liver, kidney or metabolic diseases; 5. Positive test for HIV; 6. Any other condition that contraindicates the use of radiation or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local regional failure free survival, LRFFS;Progression-Free-Survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;toxicity; | — |
Countries
China
Contacts
Public ContactAnmei Zhang
Department of oncology Second Affiliated Hospital of Army Medical University
Outcome results
None listed