Tianjin Medical University Cancer Institute and Hopital
Tianjin, Tianjin Municipality, 300000, China
Location contact
Dong Xu Wang, Ph.D
CONTACT
Lun Zhang, Ph.D
PRINCIPAL_INVESTIGATOR
Ze Zhang, MD
CONTACT
Not Yet Recruiting
NCT Number: NCT03358602
Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
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 supraglottic squamous-cell carcinoma in preoperative assessment
- Cervical node negative according to the imaging characteristics and the physical examination
- KPS≥ 70
- Normal bone marrow reserve function and normal liver, kidney function
- Expected survival period≥ 12 months
Exclusion criteria
- Inability to provide an informed consent
- Proved distant metastasis
- Clinical stage 3-4
- The patient has received prior surgery or radiotherapy (except for biopsy )
- The patient has received chemotherapy(including targeted therapies) or immunotherapy
- Prior malignancy within the previous 5 years
- Severe mental disorders
- Pregnant or lactating women
- Other disease requiring simultaneous surgery or radiotherapy
- Researchers believe that the situation is unsuitable for participation in the group
Treatment and study plan
Radiotherapy
RadiationRadiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes
Selective neck dissection
ProcedureSelective 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 outcomes
-
Neck control rates
Time frame: 2 years
The percentage of patients without cervical lymph node metastasis
Secondary outcomes
-
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 (EORTC QLQ-C30)
Time frame: 1 year
Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
-
Quality of life (EORTC QLQ-HN35)
Time frame: 1 year
Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-HN35
-
Treatment cost
Time frame: 4 weeks
The total cost of the treatment of the primary and cervical lymph nodes until the discharge
Study contacts
Contact information is provided by the study sponsor or research team.
Dong Xu Wang, Ph.D
CONTACT
Ze Zhang, MD
CONTACT
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
Radiotherapy Versus Elective Neck Dissection for Management of Cervical Nodes in Clinical T1/2N0 Supraglottic Squamous Cell Carcinoma
Important dates
- Study start
- 2017
- Primary completion
- 2025
- Study completion
- 2027
- First posted
- Nov 30, 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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