Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

Not Applicable

Not yet recruiting

• Conditions: Hypopharyngeal Carcinoma
• Interventions: Radiation: Definitive radiotherapy; Procedure: Neck dissection followed by radiotherapy(50Gy) according to risk factors

• Registration Number: NCT03367884
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-05
• Last Update Submitted: 2017-12-10
• Study First Posted: 2017-12-11
• Last Update Posted: 2017-12-12
• Study Start: 2018-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy group	Definitive radiotherapy	Definitive radiotherapy (70Gy)
Neck dissection group	Neck dissection followed by radiotherapy(50Gy) according to risk factors	Neck dissection followed by radiotherapy(50Gy) according to risk factors

Primary Outcome Measures

Name	Time	Method
Neck control rates	2 years	The percentage of patients without cervical lymph node metastasis

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	5 years	The proportion of patients did not find clear evidence of recurrence or metastasis
Overall survival	5 years	The proportion of patients who survived
Quality of life(QOL) QLQ-HN35	1 year	Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35
Quality of life(QOL) QLQ-C30	1 year	Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China