About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Neck dissection followed by radiotherapy(50Gy) according to risk factors
Procedure/SurgeryNeck dissection followed by radiotherapy(50Gy) according to risk factors
Definitive radiotherapy
RadiationDefinitive radiotherapy (70Gy)
Treatment groups
Trial outcomes
Primary outcomes
Neck control rates
The percentage of patients without cervical lymph node metastasis
Secondary outcomes
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Sponsors and contacts
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Tianjin Medical University Cancer Institute and Hospital
Lead sponsor
Tianjin Medical University Second Hospital
Collaborator
Tianjin Medical University General Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: