Unilateral Neck Radiotherapy in Head and Neck Cancer

NCT03622164 | Terminated DMC

• 1 other identifier: IIT-0002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival and disease-specific survival

  5 years after diagnosis or the start of treatment.

• University of Washington Quality of Life Questionnaire - Radiation Therapy Oncology Group (UW-QOL - RTOG) modification

  At 6, 12, 18 and 24 months post radiotherapy

• Xerostomia

  At 6, 12, 18 and 24 months post radiotherapy

• Acute toxicity

  Weekly throughout RT treatment (approximately 6 weeks)

Study Arms (2)

Non-experimental intervention

ACTIVE COMPARATOR

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)

Experimental intervention

EXPERIMENTAL

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)

Interventions

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

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

Experimental intervention

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

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

Non-experimental intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous radiation to the head and neck area
• Pregnancy
• Other contraindications to radiation treatment (e.g. severe connective tissue disease).

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 9, 2018
• Study Start: December 21, 2018
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

CA (1)