Clinical trial NCT03358602: Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer
Official title: Radiotherapy Versus Elective Neck Dissection for Management of Cervical Nodes in Clinical T1/2N0 Supraglottic Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Supraglottic Cancer
Keywords: Supraglottic cancer
Laryngeal cancer
Cervical lymph node
Neck dissection
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
name: Tianjin Medical University Second Hospital
First posted: 2017-11-30
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Neck control rates
timeFrame: 2 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 1 year
measure: Disease-free survival
timeFrame: 2 years
measure: Disease-free survival
timeFrame: 3 years
measure: Disease-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 5 years
measure: Quality of life (EORTC QLQ-C30)
timeFrame: 1 year
measure: Quality of life (EORTC QLQ-HN35)
timeFrame: 1 year
measure: Treatment cost
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hopital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Lun Zhang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: