Unilateral Neck Radiotherapy in Head and Neck Cancer

NCT ID: NCT03622164

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-21
• Study Completion Date: 2025-02-27

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.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-experimental intervention

Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck).

Group Type: ACTIVE_COMPARATOR

Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck)

Intervention Type: RADIATION

CTV54 includes the entire surgical bed, including bilateral neck lymphatics at risk of harboring microscopic disease

Experimental intervention

Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck).

Group Type: EXPERIMENTAL

Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck)

Intervention Type: RADIATION

CTV54 includes only the ipsilateral neck, including levels 2-4 plus levels 1 and/or 5 as clinically indicated.

Interventions

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.

Intervention Type: 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

Intervention Type: RADIATION

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cross Cancer Institute

OTHER

Sponsor Role: collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

IIT-0002

Identifier Type: -

Identifier Source: org_study_id