Head and Neck NeoplasmsNCT03622164
Unilateral Neck Radiotherapy in Head and Neck Cancer
A study testing Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck) and Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck) in people with Head and Neck Neoplasms, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck) and Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 21 Dec 2018to 27 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous radiation to the head and neck area
- Pregnancy
- Other contraindications to radiation treatment (e.g. severe connective tissue disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Unilateral vs. Bilateral Neck Irradiation in Head and Neck Cancer Patients Treated With Primary Surgery
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.
Read more
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
- Being tested
- Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck), Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck)
- Keywords
- radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| Non-experimental intervention | Active comparator | Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck). Receives: 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). Receives: Radiation: Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control
Locoregional failure is defined as disease recurrence (by imaging, clinical exam, or biopsy) in the neck or at the primary site.
Measured: At 24 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: At 6, 12, 18 and 24 months post radiotherapy
Xerostomia
Overall score
Measured: 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.
Measured: Weekly throughout RT treatment (approximately 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start21 Dec 2018
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Why it stopped: Lack of Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622164
- Sponsor's protocol ID
- IIT-0002
- Status last verified
- Jun 2025
- First submitted
- 9 Jul 2018
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Unilateral vs. Bilateral Neck Irradiation in Head and Neck Cancer Patients Treated With Primary Surgery
- ClinicalTrials.gov ID
- NCT03622164
- Acronym / sponsor ID
- IIT-0002
- Conditions
- Head and Neck Neoplasms
- Keywords
- radiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Accrual
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-experimental intervention | Active comparator | Radiation: Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck)Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck). |
| Experimental intervention | Experimental | Radiation: Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck)Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Previous radiation to the head and neck area
- Pregnancy
- Other contraindications to radiation treatment (e.g. severe connective tissue disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Experimental intervention |
| 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 | Radiation | Non-experimental intervention |
Primary outcome
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.
4 secondary outcomes
Overall survival and disease-specific survival
Time frame: 5 years after 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
Xerostomia
Time frame: At 6, 12, 18 and 24 months post radiotherapy
Acute toxicity
Time frame: Weekly throughout RT treatment (approximately 6 weeks)
Results and safety
The study was stopped early (reason given: Lack of Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck) and Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck) in people with Head and Neck Neoplasms, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional control (time frame: At 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.