Hypopharyngeal Carcinoma
Conditions
Keywords
Hypopharyngeal cancer, Neck dissection, Induction chemotherapy, Cervical lymph node metastasis, definitive radiotherapy
Brief summary
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.
Interventions
PROCEDURENeck dissection followed by radiotherapy(50Gy) according to risk factors
Neck dissection followed by radiotherapy(50Gy) according to risk factors
RADIATIONDefinitive radiotherapy
Definitive radiotherapy (70Gy)
Sponsors
Tianjin Medical University Second Hospital
Tianjin Medical University General Hospital
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and the willingness to sign a written informed consent document 2. Age≥ 18 and≤ 75 years 3. Histological/ cytological/ Imaging examination proven hypopharyngeal squamous-cell carcinoma in preoperative assessment 4. Advanced hypopharyngeal cancer with metastatic cervical lymph node more than 2cm in diameter 5. EPOG≤1,KPS≥ 70 6. No contraindication of surgery and radiotherapy 7. No serious disease history of the heart, liver, kidney, lung and other important organs 8. Expected survival period≥ 12 months 9. Good compliance
Exclusion criteria
1. Inability to provide an informed consent 2. Other malignancy tumor history,(except for cured skin basal cell carcinoma and papillary thyroid carcinoma) 3. Serious cardiovascular, liver, respiratory, kidney and neurologic and psychiatric disease with clinical symptoms 4. The patient has received prior surgery or radiotherapy (except for biopsy) 5. The patient has received chemotherapy or immunotherapy 6. Pregnant or lactating women 7. Other disease requiring simultaneous surgery or radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck control rates | 2 years | The percentage of patients without cervical lymph node metastasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 1 year | The proportion of patients did not find clear evidence of recurrence or metastasis |
| Overall survival | 3 years | The proportion of patients who survived |
| Quality of life(QOL) QLQ-C30 | 1 year | Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30 |
| Quality of life(QOL) QLQ-HN35 | 1 year | Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35 |
Countries
China
Contacts
Primary ContactYuansheng Duan, MD
Backup ContactZe Zhang, MD
Outcome results
None listed