Unilateral Neck Radiotherapy in Head and Neck Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03622164|
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : July 7, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Radiation: Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck) Radiation: Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial of Unilateral vs. Bilateral Neck Irradiation in Head and Neck Cancer Patients Treated With Primary Surgery|
|Actual Study Start Date :||December 21, 2018|
|Estimated Primary Completion Date :||September 2028|
|Estimated Study Completion Date :||September 2028|
Active Comparator: Non-experimental intervention
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)
CTV54 includes the entire surgical bed, including bilateral neck lymphatics at risk of harboring microscopic disease
Experimental: Experimental intervention
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.
- Locoregional control [ Time Frame: At 24 months ]Locoregional failure is defined as disease recurrence (by imaging, clinical exam, or biopsy) in the neck or at the primary site.
- Overall survival and disease-specific survival [ Time Frame: 5 years after diagnosis or the start of treatment. ]Percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.
- University of Washington Quality of Life Questionnaire - Radiation Therapy Oncology Group (UW-QOL - RTOG) modification [ Time Frame: At 6, 12, 18 and 24 months post radiotherapy ]
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.
- Xerostomia [ Time Frame: At 6, 12, 18 and 24 months post radiotherapy ]Overall score
- Acute toxicity [ Time Frame: Weekly throughout RT treatment (approximately 6 weeks) ]Toxicity scoring will be carried out to include salivary gland, mucositis, skin, and fatigue grading according the CTCAE version 4.0 scoring criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622164
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Contact: Rufus Scrimger, MD 780-432-8517 email@example.com|
|Principal Investigator: Rufus Scrimger, MD|