New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma

Conditions
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Hypopharyngeal Cancer

Intervention / Treatment
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* Drug: Induction CT+ CRT group
* Radiation: Concurrent CRT group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven squamous cell carcinoma of hypopharynx Stage III/IV M0, with T3/4 N0-3 or T1-4 N2-3 Karnofsky Performance Status>=70 Have measurable lesions on CT/MRI Treatment for the first time Expected lifetime > 6 months Normal blood test, hepatic and renal functions Normal hearing Can understand and sign the consent Have follow up condition Exclusion Criteria: Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ) Previously treatment for cancer Pregnant or breeding woman, female without contraception Enrolling in other drug trials Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes Without follow up Receive target therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Induction chemotherapy and concurret chemoradiotherapy group<br>Patients receive 2 cycles of paclitaxel, cisplatin and 5-Fluorouracil chemotherapy followed by Surgery or Chemo-radiotherapy according to the response status after induction chemo. | Drug: Induction CT+ CRT group<br>* 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<br>|
| Active Comparator: Concurrent chemoradiotherapy group<br>Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy | Radiation: Concurrent CRT group<br>* cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | 5 year | 
| distant-metastasis free survival |  | 5 year | 
| larynx-preservation rate |  | 5 year | 
| treatment related toxicities | hematology and surgery related complications | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multi-disciplinary treatment, Functional Magnetic Resonance Imaging, Hypopharyngeal carcinoma, Locally advanced, Prognosis