Clinical trial NCT03622164: Unilateral Neck Radiotherapy in Head and Neck Cancer
Official title: Randomized Trial of Unilateral vs. Bilateral Neck Irradiation in Head and Neck Cancer Patients Treated With Primary Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: radiotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2018-08-09
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Locoregional control
timeFrame: At 24 months
Secondary outcomes:
measure: Overall survival and disease-specific survival
timeFrame: 5 years after diagnosis or the start of treatment.
measure: University of Washington Quality of Life Questionnaire - Radiation Therapy Oncology Group (UW-QOL - RTOG) modification
timeFrame: At 6, 12, 18 and 24 months post radiotherapy
measure: Xerostomia
timeFrame: At 6, 12, 18 and 24 months post radiotherapy
measure: Acute toxicity
timeFrame: Weekly throughout RT treatment (approximately 6 weeks)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
References: