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

Not Applicable

Not yet recruiting

• Conditions: Supraglottic Cancer
• Interventions: Radiation: Radiotherapy; Procedure: Selective neck dissection

• Registration Number: NCT03358602
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-26
• Study First Posted: 2017-11-30
• Last Update Submitted: 2017-12-10
• Last Update Posted: 2017-12-12
• Study Start: 2017-12-20
• Primary Completion: 2025-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy	Radiotherapy	Radiotherapy \& open partial supraglottic laryngectomy(primary tumor)
Elective neck dissection	Selective neck dissection	Elective neck dissection \& open partial supraglottic laryngectomy(primary tumor)

Primary Outcome Measures

Name	Time	Method
Neck control rates	2 years	The percentage of patients without cervical lymph node metastasis

Secondary Outcome Measures

Name	Time	Method
Treatment cost	4 weeks	The total cost of the treatment of the primary and cervical lymph nodes until the discharge
Overall survival	5 years	The proportion of patients who survived
Disease-free survival	5 years	The proportion of patients did not find clear evidence of recurrence or metastasis
Quality of life (EORTC QLQ-C30)	1 year	Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Quality of life (EORTC QLQ-HN35)	1 year	Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-HN35

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hopital; 🇨🇳 Tianjin, Tianjin, China