Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03378193
Other study ID # ImpactTextureORL 29BRC17.0190
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date March 30, 2018

Study information

Verified date November 2017
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800,000 new cases and 320,000 deaths in 2015. These malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concerned squamous cell carcinomas (SCC) 90% of the time.

Despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade especially because of a high rate (up to 40%) of loco-regional recurrence. Moreover, two-third of local relapse and lymph node metastases occur in the first 2 years after treatment. Hence, predicting tumor response to therapy remains a real challenge in head and neck cancers.

Usual prognostic factors include the tumor size, the lymph node involvement, the presence of distant metastasis, the anatomic subsite, and the human papilloma virus (HPV 16, 18) infection status. However, pre-treatment selection of patients with poor prognosis or who require intensified therapy remains difficult despite their careful evaluation.

HNSCC also present a high biologic heterogeneity with hypoxic area, necrotic regions, zones of high cellular proliferation and intra-tumoral angiogenic heterogeneity. A better characterization of tumor heterogeneity could help classify patients in different risk subgroups in order to improve their therapeutic management.

Pre-therapeutic 18F-fluorodeoxyglucose positron-emission tomography (FDG PET/CT) is recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look for synchronous cancer. Its prognostic significance has already been suggested and a selection of patients at risk of recurrence appears possible using different quantitative parameters. Indeed, static (SUV = Standardized Uptake Value), volumetric (MTV = Metabolic Tumor Volume, TLG = Total Lesion Glycolysis) and kinetic (RI = Retention Index) parameters were demonstrated to be independent prognostic factors in several studies.

Texture analysis is currently highly studied in order to characterize tumor heterogeneity, and consists in extracting texture indices from different imaging modalities such as FDG PET/CT. Calculating texture indices relies on choosing a contouring method to delineate a tumor volume of interest and selecting several parameters such as the resampling method, matrix definitions and indices formula. Several studies conducted on small series of patients with HNSCC have showed promising results to predict survival, analyzing various cancer anatomic subsites, tumor segmentation methods and texture indices.

The objective of this study is to assess the prognostic value of texture indices in a large cohort of patients with HSNCC, including any anatomic subtype and staging.


Recruitment information / eligibility

Status Completed
Enrollment 284
Est. completion date March 30, 2018
Est. primary completion date March 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- biopsy proven HSNCC

- written consent

Exclusion Criteria:

- previous head and neck malignancy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prognostic value of FDG PET/CT textural indices Overall survival 2 years
See also
  Status Clinical Trial Phase
Withdrawn NCT05331131 - Efficacy of Ketamine Mouthwash in the Management of Oral and Pharyngeal Toxicity Associated With Head and Neck Chemoradiotherapy: A Phase 2, Simon 2-stage Trial Phase 2
Completed NCT05269342 - Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer N/A
Completed NCT03574870 - Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer N/A
Recruiting NCT04804852 - Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Cancer
Active, not recruiting NCT04617678 - A Comprehensive Approach to Head and Neck Cancer Prehabilitation N/A
Completed NCT03419741 - Brain Stimulation For Cancer Smokers N/A
Recruiting NCT02528955 - De-Intensification Radiotherapy Postoperative Head Neck Phase 2
Completed NCT00318890 - Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck Phase 1/Phase 2
Recruiting NCT05179824 - Tempus Priority Study: A Pan-tumor Observational Study
Recruiting NCT05316974 - Lymphoedema Among Persons With Head- and Neck Cancer
Not yet recruiting NCT03954691 - Targeting Potassium Channels to Reprogram Glioblastoma Microenvironment: in Vitro and in Vivo Studies
Active, not recruiting NCT03760471 - Palliative and Oncology Care Intervention: Symptom COACH N/A
Completed NCT04554667 - Heavy Lifting Strength Training in Head and Neck Cancer Survivors Phase 1
Completed NCT02869399 - Tertiary Prevention of Head and Neck Cancer With a Dietary Intervention N/A
Completed NCT02366611 - Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer N/A
Completed NCT02075112 - Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck Phase 1
Completed NCT00798655 - Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer Phase 2
Completed NCT02900911 - Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy N/A
Completed NCT01317589 - Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective? Phase 4
Completed NCT03841175 - Forecasts Impact of the Pre-therapeutic TEP-TDM in the 18-FDG Restaging of Upper Aero-digestive Tract Cancers