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Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03358602
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
Tianjin Medical University General Hospital
Tianjin Medical University Second Hospital
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
Supraglottic cancer is a main type of laryngeal carcinoma, which is one of the most common head and neck tumors. Cervical nodal metastasis is an important prognostic factor in supraglottic cancer. Current management, following the US National Comprehensive Cancer Network guidelines for T1-2, N0 supraglottic cancer (NCCN 2017), is either definitive radiotherapy or primary surgery with or without neck dissection. The optimal neck treatments strategy remains unclear in clinical settings owing to the limitation of a small number of retrospective studies and a lack of prospective trials. The investigators conducted a prospective, randomised trial to compare radiotherapy with neck dissection.

Condition or disease Intervention/treatment Phase
Supraglottic Cancer Radiation: Radiotherapy Procedure: Selective neck dissection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiotherapy Versus Elective Neck Dissection for Management of Cervical Nodes in Clinical T1/2N0 Supraglottic Squamous Cell Carcinoma
Estimated Study Start Date : December 20, 2017
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : November 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiotherapy
Radiotherapy & open partial supraglottic laryngectomy(primary tumor)
Radiation: Radiotherapy
Radiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes

Active Comparator: Elective neck dissection
Elective neck dissection & open partial supraglottic laryngectomy(primary tumor)
Procedure: Selective neck dissection
Selective neck dissection, defined as surgical clearance of the upper jugular (leveI II), midjugular (level III) and sometimes submandibular (level I) nodes, is used to manage the cervical lymph nodes




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 (EORTC QLQ-C30) [ Time Frame: 1 year ]
    Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

  8. Quality of life (EORTC QLQ-HN35) [ Time Frame: 1 year ]
    Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-HN35

  9. Treatment cost [ Time Frame: 4 weeks ]
    The total cost of the treatment of the primary and cervical lymph nodes until the discharge



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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 supraglottic squamous-cell carcinoma in preoperative assessment
  4. Cervical node negative according to the imaging characteristics and the physical examination
  5. KPS≥ 70
  6. Normal bone marrow reserve function and normal liver, kidney function
  7. Expected survival period≥ 12 months

Exclusion Criteria:

  1. Inability to provide an informed consent
  2. Proved distant metastasis
  3. Clinical stage 3-4
  4. The patient has received prior surgery or radiotherapy (except for biopsy )
  5. The patient has received chemotherapy(including targeted therapies) or immunotherapy
  6. Prior malignancy within the previous 5 years
  7. Severe mental disorders
  8. Pregnant or lactating women
  9. Other disease requiring simultaneous surgery or radiotherapy
  10. Researchers believe that the situation is unsuitable for participation in the group

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358602


Contacts
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Contact: Dong Xu Wang, Ph.D +86 022 23340123 wxd.1133@163.com
Contact: Ze Zhang, MD +86 022 23340123 zhangze_smu@163.com

Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hopital
Tianjin, Tianjin, China, 300000
Contact: Dong Xu Wang, Ph.D    +86 022 23340123    wxd.1133@163.com   
Contact: Ze Zhang, MD    +86 022 23340123    zhangze_smu@163.com   
Principal Investigator: Lun Zhang, Ph.D         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University General Hospital
Tianjin Medical University Second Hospital
Investigators
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Principal Investigator: Lun Zhang, Ph.D Tianjin Medical University Cancer Institute and Hospital

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT03358602    
Other Study ID Numbers: TJLC-01
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Supraglottic cancer
Laryngeal cancer
Cervical lymph node
Neck dissection