Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer
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: Radiotherapy, Selective neck dissection.
- Who it may be relevant to
- Registry conditions: Supraglottic Cancer. 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
Radiotherapy Versus Elective Neck Dissection for Management of Cervical Nodes in Clinical T1/2N0 Supraglottic Squamous Cell Carcinoma
Overview
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.
Interventions
- Radiation Radiotherapy
Radiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes - 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
- Neck control rates [Time frame: 2 years]
Secondary outcome measures (9)
- 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 (EORTC QLQ-C30) [Time frame: 1 year]
- Quality of life (EORTC QLQ-HN35) [Time frame: 1 year]
- Treatment cost [Time frame: 4 weeks]
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 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
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 Hopital — Tianjin
Identifiers
NCT: NCT03358602 · TJLC-01