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

NCT ID: NCT03358602

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2027-11-01

Brief Summary

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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

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Conditions

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Supraglottic Cancer

Keywords

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Supraglottic cancer Laryngeal cancer Cervical lymph node Neck dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiotherapy

Radiotherapy \& open partial supraglottic laryngectomy(primary tumor)

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

Radiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes

Elective neck dissection

Elective neck dissection \& open partial supraglottic laryngectomy(primary tumor)

Group Type ACTIVE_COMPARATOR

Selective neck dissection

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Radiotherapy

Radiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University Second Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lun Zhang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

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Tianjin Medical University Cancer Institute and Hopital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Central Contacts

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Dong Xu Wang, Ph.D

Role: CONTACT

Phone: +86 022 23340123

Email: [email protected]

Ze Zhang, MD

Role: CONTACT

Phone: +86 022 23340123

Email: [email protected]

Facility Contacts

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Dong Xu Wang, Ph.D

Role: primary

Ze Zhang, MD

Role: backup

Other Identifiers

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TJLC-01

Identifier Type: -

Identifier Source: org_study_id