To develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. Experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. Thus to achieve a better survival rate and a higher larynx-preservation rate as well as a lower treatment related toxicity rate compared with standard treatment.
Eligiblity patient were assign to induction chemotherapy plus concurrent chemotherapy group (IC +CCRT group, Arm A)and concurrent chemoradiotherapy group(CCRT group, Arm B). For patients in Arm A, treatment response were evaluated after 2cycles, if the response reached partial response/complete response, patients received concurrent chemoradiotherapy, otherwise, patients will received surgery and radiotherpay/concurrent chemoradiotherapy after surgery. For patients received concurrent chemoradiotherapy (both in Arm A and Arm B) , treatment response were evaluated at 50 Gy. if response reached complete response or major partial response(\>80% tumor regression), patients will received radical chemoradiotherapy, otherwise, patients will received surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Induction CT: Paclitaxel 175mg/m2 IV on d1 and d22, cisplatin 75mg/m2 IV on d1 and d22, 5-Fluorouracil 750mg/m2 IV continuously on d1-4 and d22-25, CRT: cisplatin 80mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
Cancer hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGoverall survival
Time frame: 5 year
disease free survival
Time frame: 5 year
distant-metastasis free survival
Time frame: 5 year
larynx-preservation rate
Time frame: 5 year
treatment related toxicities
hematology and surgery related complications
Time frame: 2 year
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