Supraglottic CancerNCT03358602
Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer
A study testing Radiotherapy and Selective neck dissection in people with Supraglottic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Supraglottic Cancer
- What is being tested?
- Radiotherapy and Selective neck dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2017to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hopital
Tianjin, Tianjin Municipality, 300000
Dong Xu Wang, Ph.D, +86 022 23340123, wxd.1133@163.com
Ze Zhang, MD, +86 022 23340123, zhangze_smu@163.com
About this study
Official title: 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.
- Conditions
- Supraglottic Cancer
- Being tested
- Radiotherapy, Selective neck dissection
- Keywords
- Supraglottic cancer, Laryngeal cancer, Cervical lymph node, Neck dissection
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes
Selective neck dissectionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Radiotherapy \& open partial supraglottic laryngectomy(primary tumor) Receives: Radiation: Radiotherapy |
| Elective neck dissection | Active comparator | Elective neck dissection \& open partial supraglottic laryngectomy(primary tumor) Receives: Procedure: Selective neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck control rates
The percentage of patients without cervical lymph node metastasis
Measured: 2 years
Secondary outcomes (9)
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Measured: 1 year
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Measured: 2 years
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Measured: 3 years
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Measured: 5 years
Overall survival
The proportion of patients who survived
Measured: 3 years
Overall survival
The proportion of patients who survived
Measured: 5 years
Quality of life (EORTC QLQ-C30)
Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Measured: 1 year
Quality of life (EORTC QLQ-HN35)
Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-HN35
Measured: 1 year
Treatment cost
The total cost of the treatment of the primary and cervical lymph nodes until the discharge
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start20 Dec 2017 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Tianjin Medical University Second Hospital
- Responsible party
- Sponsor
- Investigators
- Lun Zhang, Ph.D, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358602
- Sponsor's protocol ID
- TJLC-01
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy Versus Elective Neck Dissection for Management of Cervical Nodes in Clinical T1/2N0 Supraglottic Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03358602
- Acronym / sponsor ID
- TJLC-01
- Conditions
- Supraglottic Cancer
- Keywords
- Supraglottic cancer, Laryngeal cancer, Cervical lymph node, Neck dissection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Tianjin Medical University Second Hospital
- Study start
- 20 Dec 2017 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: RadiotherapyRadiotherapy \& open partial supraglottic laryngectomy(primary tumor) |
| Elective neck dissection | Active comparator | Procedure: Selective neck dissectionElective neck dissection \& open partial supraglottic laryngectomy(primary tumor) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes | Radiation | Radiotherapy |
| Selective neck dissectionSelective 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 | Procedure or surgery | Elective neck dissection |
Primary outcome
Neck control rates
Time frame: 2 years
The percentage of patients without cervical lymph node metastasis
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
Related trials for Supraglottic Cancer
RecruitingObservational study
Clinical Treatments in Specialized Diseases of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC)
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Active, not recruiting
Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma
Oropharyngeal Cancer, Supraglottic Squamous Cell Carcinoma
RecruitingObservational study
Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies
Supraglottic Squamous Cell Carcinoma, Early Stage (T1-T2, N0-N1,M0)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lun Zhang, Ph.D principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy and Selective neck dissection in people with Supraglottic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Xu Wang, Ph.D (+86 022 23340123, wxd.1133@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck control rates (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.