Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Laryngeal Cancer

Radiotherapy \& open partial supraglottic laryngectomy(primary tumor)

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

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

Radiotherapy

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

Selective neck dissection

Dong Xu Wang, Ph.D

Ze Zhang, MD

Lun Zhang, Ph.D

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.

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

The percentage of patients without cervical lymph node metastasis

The proportion of patients did not find clear evidence of recurrence or metastasis

Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-HN35

The total cost of the treatment of the primary and cervical lymph nodes until the discharge

Tianjin Medical University General Hospital

Tianjin Medical University Second Hospital

Tianjin Medical University Cancer Institute and Hospital

Head and Neck Neoplasms

All patients with a histologically confirmed squamous cell carcinoma in the head and neck region

Whartin tumour or pleomorphic adenoma of the parotid gland without malignant transformation

Johan Abeloos, MD

The investigators aim to validate specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region. Moreover, we aim to explore specific MRI parameters that could improve diagnostic accuracy of bone invasion and tumour relapse, as well as predict treatment response and survival in this target population.

Background: The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes, bone invasion, or tumour relapse in a previously irradiated or operated field remains challenging. Technological advances in magnetic resonance imaging (MRI) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance. Moreover, they could provide additional information about radiation and/or chemotherapeutic efficiency in an individual patient.

Objectives: The investigators aim to validate specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region. Moreover, we aim to explore specific MRI parameters that could improve diagnostic accuracy of bone invasion and tumour relapse, as well as predict treatment response and survival in this target population.

Methods: In this trial, a validation cohort will be recruited in a prospective manner, to validate the MRI parameters that showed clinically acceptable discriminant value based on the retrospective study. The values of the selected MRI parameters will be calculated in metastatic lymph nodes of the affected group, for comparison with their values measured in the lymph nodes of a prospectively recruited control group, comprising patients who require the same standardized MRI protocol for evaluation of a Whartin tumour or pleomorphic adenoma of the parotid gland without malignant transformation, and in whom both the parotid gland lesion and the cervical lymph node are surgically removed for histological confirmation. All included patients of the 'affected group' will also undergo a preoperative positron emission tomography-computed tomography (PET-CT), according to international guidelines, and will preferably receive a multiparametric MRI at 3, 6, 12, 24, 36, 48 and 60 months post treatment as part of routine follow-up.

Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Prospective Analysis

Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer: a Prospective Analysis

MRI parameters will be considered validated if they enable differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'

MRI parameters will be considered validated if they enable differentiation between tumoural bone invasion and no bone invasion, as based on the final pathology report as the 'gold standard'

MRI parameters will be considered validated if they enable differentiation between post-therapeutic sequelae and tumour relapse, as based on the final pathology report as the 'gold standard'

predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria

AZ Sint-Jan AV

head of department

patients with a histologically confirmed head and neck tumour

histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation

multiparametric MRI

The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.

Background:The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes remains challenging. Technological advances in magnetic resonance imaging (MRI) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance.

Objectives: The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.

Study design: a retrospective study will be set up to explore the diagnostic performance of the selected MRI parameters to differentiate between tumoural and non-tumoural cervical lymph nodes in patients with a histologically confirmed head and neck tumour ('affected group') or histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation ('control group').

Patients will be screened for inclusion in the analysis if they had a routine preoperative multiparametric MRI, according to a standardised protocol, between the 1st of December 2016 and the 30th of September 2018. All MR images will be screened by the resident to select those patients with one or multiple clearly distinguishable metastatic cervical lymph node(s), which can be clearly correlated with the final pathology report. Other strict inclusion criteria are described in detail in the protocol.

Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Retrospective Analysis

Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer

differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer	NCT03358602	Supraglottic Ca...	Radiotherapy Selective neck ...	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital
Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Prospective Analysis	NCT03993665	Head and Neck C... Multiparametric... Cervical Lymph ... Bone Invasion Tumour Relapse Treatment Respo...		18 Years -	AZ Sint-Jan AV
Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Retrospective Analysis	NCT03991533	Head and Neck C... Multiparametric... Cervical Lymph ...	multiparametric...	18 Years -	AZ Sint-Jan AV
Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Retrospective Analysis	NCT03991533	Head and Neck C... Multiparametric... Cervical Lymph ...	multiparametric...	18 Years -	AZ Sint-Jan AV

Spots Global Cancer Trial Database for cervical lymph node