Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

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

Qualifiers

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

Treatments tested in this trial

  • Neck dissection followed by radiotherapy(50Gy) according to risk factors
  • Definitive radiotherapy

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Tianjin Medical University Second Hospital

Collaborator

Tianjin Medical University General Hospital

Collaborator