An interventional study of Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck) and Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck) in Head and Neck Neoplasms, sponsored by AHS Cancer Control Alberta. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by AHS Cancer Control Alberta · Not applicable, Interventional, and Treatment
Patients with head and neck cancer typically undergo a surgical procedure to remove the lymph nodes that could contain disease on both sides of the neck. After surgery, radiotherapy is given (with or without chemotherapy) to the area that underwent surgery and both sides of the neck, even if disease was only found on one side. Giving radiotherapy to both sides of the neck commonly results in high rates of side effects, which in turn affects patient quality of life.
There is growing evidence from some other studies that support the safety of omitting radiotherapy after surgery in the side of the neck with no disease. With this study, the investigators are hoping to justify its routine use and, if successful, the standard of care could be to receive radiation on only one side of the neck instead of both sides. This could alleviate the extent of some side effects and improve patient quality of life.
Participants will be randomized into one of the following groups to receive radiotherapy as follows:
Arm 1 (Non-experimental intervention): standard intervention: Radiotherapy to both sides of the neck. Treatment will begin a maximum of 8 weeks from the surgery date.
Arm 2 (Experimental intervention): Radiotherapy to one side of the neck. Treatment will begin a maximum of 8 weeks from the surgery date.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's enrollment of 22 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with squamous cell carcinoma of the head and neck undergoing primary surgical management are eligible to participate if they meet the following eligibility criteria:
Exclusion Criteria:
Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck).
Radiation: Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck)
Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck).
Radiation: Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck)
CTV54 includes only the ipsilateral neck, including levels 2-4 plus levels 1 and/or 5 as clinically indicated.
CTV54 includes the entire surgical bed, including bilateral neck lymphatics at risk of harboring microscopic disease
Locoregional control
Locoregional failure is defined as disease recurrence (by imaging, clinical exam, or biopsy) in the neck or at the primary site.
Time frame: At 24 months
Overall survival and disease-specific survival
Percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.
Time frame: 5 years after diagnosis or the start of treatment.
University of Washington Quality of Life Questionnaire - Radiation Therapy Oncology Group (UW-QOL - RTOG) modification
The University of Washington Quality of Life questionnaire Radiation Therapy Oncology Group (RTOG) modification, is a health related quality of life tool for use in head and neck cancer patients receiving RT. The UW-QOL RTOG modification consists of 15 items with response options ranging from 10 to 50, in multiples of 10. That is, the lowest symptom burden is rated as 10, whereas the highest symptom burden is rated as 50. The individual item scores are totaled and then averaged to obtain the final score. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower HRQOL.
Time frame: At 6, 12, 18 and 24 months post radiotherapy
Xerostomia
Overall score
Time frame: At 6, 12, 18 and 24 months post radiotherapy
Acute toxicity
Toxicity scoring will be carried out to include salivary gland, mucositis, skin, and fatigue grading according the CTCAE version 4.0 scoring criteria.
Time frame: Weekly throughout RT treatment (approximately 6 weeks)
This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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AHS Cancer Control Alberta