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Not yet recruiting NCT03367884

Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

No phase Interventional Hypopharyngeal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neck dissection followed by radiotherapy(50Gy) according to risk factors, Definitive radiotherapy.
Who it may be relevant to
Registry conditions: Hypopharyngeal Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Neck control rates [Time frame: 2 years]
Secondary outcome measures (8)
  • Disease-free survival [Time frame: 1 year]
  • Disease-free survival [Time frame: 2 years]
  • Disease-free survival [Time frame: 3 years]
  • Disease-free survival [Time frame: 5 years]
  • Overall survival [Time frame: 3 years]
  • Overall survival [Time frame: 5 years]
  • Quality of life(QOL) QLQ-C30 [Time frame: 1 year]
  • Quality of life(QOL) QLQ-HN35 [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Ability to understand and the willingness to sign a written informed consent document
  • Age≥ 18 and≤ 75 years
  • Histological/ cytological/ Imaging examination proven hypopharyngeal squamous-cell carcinoma in preoperative assessment
  • Advanced hypopharyngeal cancer with metastatic cervical lymph node more than 2cm in diameter
  • EPOG≤1,KPS≥ 70
  • No contraindication of surgery and radiotherapy
  • No serious disease history of the heart, liver, kidney, lung and other important organs
  • Expected survival period≥ 12 months
  • Good compliance

Exclusion criteria

  • Inability to provide an informed consent
  • Other malignancy tumor history,(except for cured skin basal cell carcinoma and papillary thyroid carcinoma)
  • Serious cardiovascular, liver, respiratory, kidney and neurologic and psychiatric disease with clinical symptoms
  • The patient has received prior surgery or radiotherapy (except for biopsy)
  • The patient has received chemotherapy or immunotherapy
  • Pregnant or lactating women
  • Other disease requiring simultaneous surgery or radiotherapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT03367884 · TJHPC-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗