Unilateral Neck Radiotherapy in Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Randomized Trial of Unilateral vs. Bilateral Neck Irradiation in Head and Neck Cancer Patients Treated With Primary Surgery

Conditions
-----------------
Head and Neck Neoplasms

Intervention / Treatment
-----------------
* 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)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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: Age ≥18 Primary site of disease in the oral cavity, oropharynx, larynx, or hypopharynx. Squamous cell carcinoma confirmed by histology. Bilateral modified radical or selective neck dissections carried out as part of primary surgery, with >= 10 lymph nodes removed from the contralateral neck The contralateral neck is pathologically negative Pre-surgical FDG-PET/CT scan did not show any clinically involved contralateral neck nodes. Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up. Exclusion Criteria: Previous radiation to the head and neck area Pregnancy Other contraindications to radiation treatment (e.g. severe connective tissue disease).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-experimental intervention<br>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)<br>* CTV54 includes the entire surgical bed, including bilateral neck lymphatics at risk of harboring microscopic disease<br>|
| Experimental: Experimental intervention<br>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)<br>* CTV54 includes only the ipsilateral neck, including levels 2-4 plus levels 1 and/or 5 as clinically indicated.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control | Locoregional failure is defined as disease recurrence (by imaging, clinical exam, or biopsy) in the neck or at the primary site. | At 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At 6, 12, 18 and 24 months post radiotherapy | 
| Xerostomia | Overall score | 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. | Weekly throughout RT treatment (approximately 6 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiotherapy