Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

Study Overview
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Brief Summary
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At the time of diagnosis, approximately 60%-80% of patients with hypopharyngeal cancer are found with cervical lymph node metastasis. Cervical nodal metastasis is an important prognostic factor in hypopharyngeal cancer. Induction chemotherapy is frequently used in advanced hypopharynx cancer. However, sometimes CR was obtained at the tumor's primary site but not in the palpable lymph nodes in the neck, the large cervical lymph node metastasis poorly responded to induction chemotherapy in a considerable percentage of patients. At present, patients with primary tumor achieved CR preferred to receive definitive radiotherapy no matter cervical lymph node metastasis SD or progression. But, radiotherapy was poor effective to the big cervical lymph node metastasis, because the inner of big cervical lymph node metastasis was hypoxic and necrosis. The investigators conducted a prospective, randomised trial to compare neck dissection with definitive radiotherapy for advanced hypopharyngeal cancer cervical lymph node metastasis with poor response to induction chemotherapy.

Official Title
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Neck Dissection Versus Radiotherapy for Cervical Lymph Node Metastasis in Advanced Hypopharyngeal Carcinoma With Poor Response to Induction Chemotherapy : A Randomized Controlled Prospective Study

Conditions
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Hypopharyngeal Carcinoma

Intervention / Treatment
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* Procedure: Neck dissection followed by radiotherapy(50Gy) according to risk factors
* Radiation: Definitive radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document Age≥ 18 and≤ 75 years Histological/ cytological/ Imaging examination proven hypopharyngeal squamous-cell carcinoma in preoperative assessment Advanced hypopharyngeal cancer with metastatic cervical lymph node more than 2cm in diameter EPOG≤1,KPS≥ 70 No contraindication of surgery and radiotherapy No serious disease history of the heart, liver, kidney, lung and other important organs Expected survival period≥ 12 months Good compliance Exclusion Criteria: Inability to provide an informed consent Other malignancy tumor history,(except for cured skin basal cell carcinoma and papillary thyroid carcinoma) Serious cardiovascular, liver, respiratory, kidney and neurologic and psychiatric disease with clinical symptoms The patient has received prior surgery or radiotherapy (except for biopsy) The patient has received chemotherapy or immunotherapy Pregnant or lactating women Other disease requiring simultaneous surgery or radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Neck dissection group<br>Neck dissection followed by radiotherapy(50Gy) according to risk factors | Procedure: Neck dissection followed by radiotherapy(50Gy) according to risk factors<br>* Neck dissection followed by radiotherapy(50Gy) according to risk factors<br>|
| Active Comparator: Radiotherapy group<br>Definitive radiotherapy (70Gy) | Radiation: Definitive radiotherapy<br>* Definitive radiotherapy (70Gy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck control rates | The percentage of patients without cervical lymph node metastasis | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis | 1 year | 
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis | 2 years | 
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis | 3 years | 
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis | 5 years | 
| Overall survival | The proportion of patients who survived | 3 years | 
| Overall survival | The proportion of patients who survived | 5 years | 
| Quality of life(QOL) QLQ-C30 | Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30 | 1 year | 
| Quality of life(QOL) QLQ-HN35 | Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypopharyngeal cancer, Neck dissection, Induction chemotherapy, Cervical lymph node metastasis, definitive radiotherapy