Clinical trial NCT03367884: Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypopharyngeal Carcinoma
Keywords: Hypopharyngeal cancer
Neck dissection
Induction chemotherapy
Cervical lymph node metastasis
definitive radiotherapy
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University Second Hospital
name: Tianjin Medical University General Hospital
First posted: 2017-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Neck control rates
timeFrame: 2 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 1 year
measure: Disease-free survival
timeFrame: 2 years
measure: Disease-free survival
timeFrame: 3 years
measure: Disease-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 5 years
measure: Quality of life(QOL) QLQ-C30
timeFrame: 1 year
measure: Quality of life(QOL) QLQ-HN35
timeFrame: 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Xudong Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: