NCT03358602Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Dec 2017 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- First submitted
- 21 Nov 2017
- Start date
- 20 Dec 2017
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT03358602
What you commit to
- Study type: Interventional
- Planned participants: 158
- From 20 Dec 2017 to the primary completion date, 1 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient has received prior surgery or radiotherapy (except for biopsy )
- The patient has received chemotherapy(including targeted therapies) or immunotherapy
Other illness
- Prior malignancy within the previous 5 years
- Severe mental disorders
- Other disease requiring simultaneous surgery or radiotherapy
Other
- Inability to provide an informed consent
- Proved distant metastasis
- Clinical stage 3-4
- Pregnant or lactating women
- Researchers believe that the situation is unsuitable for participation in the group
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hopital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.