This study is being done to answer the following question: Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck?
This study is being conducted in order to find out if this approach is as good as the usual approach in controlling the cancer and has fewer side effects and better quality of life. The usual approach for patients who are not in a study is treatment which includes radiotherapy to the tumour and to both sides of the neck to decrease the risk of spread or recurrence of the cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
510
Radiation: Ipsilateral Neck Radiotherapy and SPECT-CT Guided Contralateral Neck Radiotherapy
Radiotherapy
Disease-free Survival
Time frame: 8 years
Quality of Life using M.D. Anderson Dysphagia Inventory (MDADI)
Possible range of scores between 0 and 100 (higher scores indicating better swallowing and lower score indicating poor swallowing).
Time frame: 8 years
Xerostomia-related Quality of Life using Xerostomia Questionnaire (XQ)
Clinically meaningful worsening of xerostomia (10 units on XQ) from baseline to 12 months post RT
Time frame: 8 years
Isolated contralateral neck failure (iCNF)
Time frame: 8 years
Overall Survival (OS)
Time frame: 8 years
Logo-regional Failure (LRF)
Time frame: 8 years
Distant Metastases (DM)
Time frame: 8 years
Incidence and Severity of Radiation-related Toxicities
Time frame: 8 years
Patient-Reported Toxicities using PRO CTCAE
Time frame: 8 years
Gastrostomy Tube Usage
Time frame: 8 years
Resource Utilization
Time frame: 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
City of Hope Corona
Corona, California, United States
RECRUITINGCity of Hope Comprehensive Cancer Center
Duarte, California, United States
RECRUITINGCity of Hope at Irvine Lennar
Irvine, California, United States
SUSPENDEDUM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
RECRUITINGBaptist MD Anderson Cancer Center
Jacksonville, Florida, United States
ACTIVE_NOT_RECRUITINGUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
RECRUITINGMoffitt Cancer Center-International Plaza
Tampa, Florida, United States
RECRUITINGMoffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGEmory University Hospital Midtown
Atlanta, Georgia, United States
RECRUITING...and 28 more locations
Lost Productivity
Healthcare system and societal resources will be quantified over the course of the trial to generate utilization information by patient in each study arm. We will generate an average cost per study subject by treatment arm for an overall mean cost per study arm
Time frame: 8 years
Financial Toxicity [Financial Index of Toxicity (FIT)]
Time frame: 8 years
Health Utilities using EQ-5D
Time frame: 8 years