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出境医 / 临床实验 / Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypopharyngeal Carcinoma Procedure: Neck dissection followed by radiotherapy(50Gy) according to risk factors Radiation: Definitive radiotherapy Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2028
Arms and Interventions
Arm Intervention/treatment
Experimental: Neck dissection group
Neck dissection followed by radiotherapy(50Gy) according to risk factors
 Procedure: Neck dissection followed by radiotherapy(50Gy) according to risk factors
Neck dissection followed by radiotherapy(50Gy) according to risk factors
Active Comparator: Radiotherapy group
Definitive radiotherapy (70Gy)
 Radiation: Definitive radiotherapy
Definitive radiotherapy (70Gy)
Outcome Measures
Primary Outcome Measures :
  1. Neck control rates [ Time Frame: 2 years ]
    The percentage of patients without cervical lymph node metastasis


Secondary Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Yuansheng Duan, MD +86 022 23340123 duanyuansheng89@163.com
Contact: Ze Zhang, MD +86 022 23340123 zhangze_smu@163.com

Locations
Layout table for location information
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China, 300000
Contact: Yuansheng Duan, MD    +86 022 23340123    duanyuansheng89@163.com   
Contact: Ze Zhang, MD    +86 022 23340123    zhangze_smu@163.com   
Principal Investigator: Xudong Wang, Ph.D         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Second Hospital
Tianjin Medical University General Hospital
Investigators
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Principal Investigator: Xudong Wang, Ph.D Tianjin Medical University Cancer Institute and Hospital
Tracking Information
First Submitted Date  ICMJE December 5, 2017
First Posted Date  ICMJE December 11, 2017
Last Update Posted Date December 12, 2017
Estimated Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2017) 		Neck control rates [ Time Frame: 2 years ]
The percentage of patients without cervical lymph node metastasis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2017)
  • Disease-free survival [ Time Frame: 1 year ]
    The proportion of patients did not find clear evidence of recurrence or metastasis
  • Disease-free survival [ Time Frame: 2 years ]
    The proportion of patients did not find clear evidence of recurrence or metastasis
  • Disease-free survival [ Time Frame: 3 years ]
    The proportion of patients did not find clear evidence of recurrence or metastasis
  • Disease-free survival [ Time Frame: 5 years ]
    The proportion of patients did not find clear evidence of recurrence or metastasis
  • Overall survival [ Time Frame: 3 years ]
    The proportion of patients who survived
  • Overall survival [ Time Frame: 5 years ]
    The proportion of patients who survived
  • Quality of life(QOL) QLQ-C30 [ Time Frame: 1 year ]
    Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30
  • Quality of life(QOL) QLQ-HN35 [ Time Frame: 1 year ]
    Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
  • Disease-free survival [ Time Frame: 1 year ]
    The proportion of patients did not find clear evidence of recurrence or metastasis
  • Disease-free survival [ Time Frame: 2 years ]
    The proportion of patients did not find clear evidence of recurrence or metastasis
  • Disease-free survival [ Time Frame: 3 years ]
    The proportion of patients did not find clear evidence of recurrence or metastasis
  • Disease-free survival [ Time Frame: 5 years ]
    The proportion of patients did not find clear evidence of recurrence or metastasis
  • Overall survival [ Time Frame: 3 years ]
    The proportion of patients who survived
  • Overall survival [ Time Frame: 5 years ]
    The proportion of patients who survived
  • Quality of life(QOL) QLQ-C30 [ Time Frame: 1 year ]
    Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30
  • Quality of life(QOL) QLQ-HN35 [ Time Frame: 1 year ]
    Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35
  • Clinical complications and toxic effects. [ Time Frame: 4 weeks ]
    Complications and toxicity during treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer
Official Title  ICMJE Neck Dissection Versus Radiotherapy for Cervical Lymph Node Metastasis in Advanced Hypopharyngeal Carcinoma With Poor Response to Induction Chemotherapy : A Randomized Controlled Prospective Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypopharyngeal Carcinoma
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: Neck dissection group
    Neck dissection followed by radiotherapy(50Gy) according to risk factors
    Intervention: Procedure: Neck dissection followed by radiotherapy(50Gy) according to risk factors
  • Active Comparator: Radiotherapy group
    Definitive radiotherapy (70Gy)
    Intervention: Radiation: Definitive radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2017) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2028
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yuansheng Duan, MD +86 022 23340123 duanyuansheng89@163.com
Contact: Ze Zhang, MD +86 022 23340123 zhangze_smu@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03367884
Other Study ID Numbers  ICMJE TJHPC-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tianjin Medical University Cancer Institute and Hospital
Study Sponsor  ICMJE Tianjin Medical University Cancer Institute and Hospital
Collaborators  ICMJE
  • Tianjin Medical University Second Hospital
  • Tianjin Medical University General Hospital
Investigators  ICMJE
Principal Investigator: Xudong Wang, Ph.D Tianjin Medical University Cancer Institute and Hospital
PRS Account Tianjin Medical University Cancer Institute and Hospital
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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