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

Radiotherapy Versus Elective Neck Dissection for Management of Cervical Nodes in Clinical T1/2N0 Supraglottic Squamous Cell Carcinoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Supraglottic Cancer
• Intervention / Treatment: Radiation: Radiotherapy; Procedure: Selective neck dissection

• Study Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong Xu Wang, Ph.D; Phone Number: +86 022 23340123; Email: wxd.1133@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Tianjin Medical University Cancer Institute and Hopital
      • Contact: Dong Xu Wang, Ph.D; Phone Number: +86 022 23340123; Email: wxd.1133@163.com
      • Principal Investigator: Lun Zhang, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck control rates	The percentage of patients without cervical lymph node metastasis	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	1 year
Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	2 years
Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	3 years
Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	5 years
Overall survival	The proportion of patients who survived	3 years
Overall survival	The proportion of patients who survived	5 years
Quality of life (EORTC QLQ-C30)	Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30	1 year
Quality of life (EORTC QLQ-HN35)	Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-HN35	1 year
Treatment cost	The total cost of the treatment of the primary and cervical lymph nodes until the discharge	4 weeks

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Tianjin Medical University General Hospital; Tianjin Medical University Second Hospital
• Investigators: Principal Investigator: Lun Zhang, Ph.D, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2017
• Primary Completion (Anticipated): November 1, 2025
• Study Completion (Anticipated): November 1, 2027

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 26, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 10, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Laryngeal cancer; Neck dissection; Supraglottic cancer; Cervical lymph node
• Other Study ID Numbers: TJLC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No