Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

Hypopharyngeal Carcinoma Clinical Trial

Official title:

Neck Dissection Versus Radiotherapy for Cervical Lymph Node Metastasis in Advanced Hypopharyngeal Carcinoma With Poor Response to Induction Chemotherapy : A Randomized Controlled Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03367884
• Other study ID #: TJHPC-01
• Status: Not yet recruiting
• Phase: N/A
• First received: December 5, 2017
• Last updated: December 10, 2017
• Start date: January 1, 2018
• Est. completion date: January 1, 2028

Study information

• Verified date: November 2017
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Yuansheng Duan, MD
• Phone: +86 022 23340123
• Email: duanyuansheng89[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Hypopharyngeal Carcinoma
• Hypopharyngeal Neoplasms
• Neoplasm Metastasis

Intervention

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

Radiation:
• Definitive radiotherapy
Definitive radiotherapy (70Gy)

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (3)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Tianjin Medical University General Hospital, Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck control rates	The percentage of patients without cervical lymph node metastasis	2 years
Secondary	Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	1 year
Secondary	Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	2 years
Secondary	Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	3 years
Secondary	Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	5 years
Secondary	Overall survival	The proportion of patients who survived	3 years
Secondary	Overall survival	The proportion of patients who survived	5 years
Secondary	Quality of life(QOL) QLQ-C30	Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30	1 year
Secondary	Quality of life(QOL) QLQ-HN35	Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35	1 year