Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

NCT03367884 · tracked via the Priya Life Science China tracker

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Phase

Not applicable

Started

2018-01-01

Last updated

2017-12-12

Condition(s) studied

Hypopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

Neck dissection followed by radiotherapy(50Gy) according to risk factorsDefinitive radiotherapy

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

Definitive radiotherapy: Definitive radiotherapy (70Gy)

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Neck control rates — 2 years
The percentage of patients without cervical lymph node metastasis

Trial sites (1)

Facility	City	Region	Status
Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03367884 on ClinicalTrials.gov ↗ ← All trials in China