Clinical trial · Interventional
Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer
Neck Dissection Versus Radiotherapy for Cervical Lymph Node Metastasis in Advanced Hypopharyngeal Carcinoma With Poor Response to Induction Chemotherapy : A Randomized Controlled Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypopharyngeal Carcinoma | Hypopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Definitive radiotherapy | Radiation | — | UNRESOLVED |
| Neck dissection followed by radiotherapy(50Gy) according to risk factors | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neck dissection group
- description
- Neck dissection followed by radiotherapy(50Gy) according to risk factors
- interventionNames
- Procedure: Neck dissection followed by radiotherapy(50Gy) according to risk factors
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy group
- description
- Definitive radiotherapy (70Gy)
- interventionNames
- Radiation: Definitive radiotherapy
Primary outcomes (1)
- measure
- Neck control rates
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available