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

Tianjin Medical University

Status: Not yet enrolling

Conditions: Supraglottic Cancer

Treatments: Procedure: Selective neck dissection; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03358602

TJLC-01

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

158 participants in 2 patient groups

Radiotherapy

Experimental group

Description:

Radiotherapy \& open partial supraglottic laryngectomy(primary tumor)

Treatment:

Radiation: Radiotherapy

Elective neck dissection

Active Comparator group

Description:

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

Treatment:

Procedure: Selective neck dissection