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NCT Number: NCT03367884

Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

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.

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Key information

Conditions

Hypopharyngeal Carcinoma Head and Neck Neoplasms Hypopharyngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Definitive radiotherapy

Radiation

Definitive radiotherapy (70Gy)

Primary outcomes

  1. Neck control rates

    Time frame: 2 years

    The percentage of patients without cervical lymph node metastasis

Secondary outcomes

  1. Disease-free survival

    Time frame: 1 year

    The proportion of patients did not find clear evidence of recurrence or metastasis

  2. Disease-free survival

    Time frame: 2 years

    The proportion of patients did not find clear evidence of recurrence or metastasis

  3. Disease-free survival

    Time frame: 3 years

    The proportion of patients did not find clear evidence of recurrence or metastasis

  4. Disease-free survival

    Time frame: 5 years

    The proportion of patients did not find clear evidence of recurrence or metastasis

  5. Overall survival

    Time frame: 3 years

    The proportion of patients who survived

  6. Overall survival

    Time frame: 5 years

    The proportion of patients who survived

  7. Quality of life(QOL) QLQ-C30

    Time frame: 1 year

    Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30

  8. Quality of life(QOL) QLQ-HN35

    Time frame: 1 year

    Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35

Study contacts

Contact information is provided by the study sponsor or research team.

Yuansheng Duan, MD

CONTACT

[email protected]

+86 022 23340123

Ze Zhang, MD

CONTACT

[email protected]

+86 022 23340123

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

  • Tianjin Medical University General Hospital
  • Tianjin Medical University Second Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2024
Study completion
2028
First posted
Dec 11, 2017
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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