Unilateral vs Bilateral Radiotherapy for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: AHS Cancer Control Alberta

Disqualifiers: Previous radiation, Pregnancy, Connective tissue disease

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing whether giving radiation to only one side of the neck, instead of both, can be just as effective for patients with head and neck cancer who have had surgery. The goal is to see if this approach can reduce side effects and improve quality of life. Radiation treatment works by using high-energy rays to destroy cancer cells.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for head and neck cancer?

Research shows that using unilateral radiotherapy (radiation to one side of the neck) for certain head and neck cancers, like well-lateralized tonsil cancer, can effectively control the tumor while reducing side effects compared to treating both sides. ^{1 2 3 4 5}

Is unilateral radiotherapy safe for head and neck cancer?

Research on unilateral radiotherapy, particularly for tonsil cancer, suggests it is generally safe, with studies focusing on its effectiveness and potential risks like contralateral nodal failure (cancer spreading to the opposite side of the neck). ^{2 3 6 7 8}

How does unilateral vs bilateral radiotherapy for head and neck cancer differ from other treatments?

This treatment is unique because it compares targeting only one side of the neck (unilateral) versus both sides (bilateral) with radiotherapy, which can help reduce side effects by sparing healthy tissue while still effectively treating the cancer. This approach is particularly considered for well-lateralized tumors, where the cancer is confined to one side, potentially lowering the risk of unnecessary radiation exposure to the opposite side. ^{1 2 3 4 5}

Eligibility Criteria

Adults over 18 with squamous cell carcinoma of the head and neck who've had surgery to remove lymph nodes, with no disease found on one side. They must understand and agree to the study's process, have had a PET/CT scan showing no disease on the opposite side, and be able to follow treatment and check-ups.

Inclusion Criteria

My cancer is confirmed as squamous cell carcinoma.

I have squamous cell carcinoma in my head or neck and am having surgery as my first treatment.

The contralateral neck is pathologically negative

Exclusion Criteria

Pregnancy

I have had radiation therapy to my head or neck.

I do not have severe conditions that make radiation unsafe for me.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Surgical procedure to remove lymph nodes on both sides of the neck

1 day

1 visit (in-person)

Radiotherapy

Radiotherapy to either one or both sides of the neck, starting a maximum of 8 weeks post-surgery

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 6, 12, 18, and 24 months post-radiotherapy

Treatment Details

Interventions

• Radiotherapy to ipsilateral neck lymphatics and tumor bed (Radiation Therapy)
• Radiotherapy to the bilateral neck lymphatics and tumor bed (Radiation Therapy)

Trial Overview This trial is testing if it's safe for patients with head and neck cancer to receive radiotherapy only on the affected side of their neck instead of both sides after surgery. Participants are randomly placed in two groups: one gets standard radiotherapy on both sides; the other gets experimental therapy just on one side.

Participant Groups

Group I: Experimental intervention Experimental Treatment 1 Intervention

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

Group II: Non-experimental intervention Active Control 1 Intervention

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

Radiotherapy to ipsilateral neck lymphatics and tumor bed is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Unilateral Neck Radiotherapy for:

• Head and neck cancer
• Squamous cell carcinoma of the tonsil
• Oropharyngeal carcinoma

🇺🇸 Approved in United States as Unilateral Neck Radiotherapy for:

• Head and neck cancer
• Squamous cell carcinoma of the tonsil
• Oropharyngeal carcinoma

🇨🇦 Approved in Canada as Unilateral Neck Radiotherapy for:

• Head and neck cancer
• Squamous cell carcinoma of the tonsil
• Oropharyngeal carcinoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cross Cancer Institute Edmonton, Canada

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta Lead Sponsor

Cross Cancer Institute Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Bilateral vs ipsilateral adjuvant radiotherapy in patients with cancer of unknown primary of the head and neck: An analysis of the clinical outcome and radiation-induced side effects. [2020] The purpose of this study was to analyze and compare ipsilateral and bilateral adjuvant radiotherapy in patients with cancer of unknown primary (CUP) of the head and neck.

2. United States pubmed.ncbi.nlm.nih.gov

Freedom from local and regional failure of contralateral neck with ipsilateral neck radiotherapy for node-positive tonsil cancer: results of a prospective management approach. [2009] To review the outcomes of a prospective management approach using ipsilateral neck radiotherapy in the treatment of node-positive squamous cell carcinoma of the tonsil with a well-lateralized primary lesion.

3. England pubmed.ncbi.nlm.nih.gov

Ipsilateral irradiation for well lateralized carcinomas of the oral cavity and oropharynx: results on tumor control and xerostomia. [2021] In head and neck cancer, bilateral neck irradiation is the standard approach for many tumor locations and stages. Increasing knowledge on the pattern of nodal invasion leads to more precise targeting and normal tissue sparing. The aim of the present study was to evaluate the morbidity and tumor control for patients with well lateralized squamous cell carcinomas of the oral cavity and oropharynx treated with ipsilateral radiotherapy.

4. United States pubmed.ncbi.nlm.nih.gov

Radiotherapeutic management of cervical lymph node metastases from an unknown primary site. [2012] To determine whether ipsilateral radiotherapy affects overall survival, cause-specific survival, or local control in patients with a cancer from an unknown primary of the head and neck compared with comprehensive radiotherapy.

5. United States pubmed.ncbi.nlm.nih.gov

Long-term Locoregional Control With Unilateral Radiation for AJCC-7 T1-2N2b Tonsillar Cancer. [2023] Unilateral radiation to cervical nodes has been used as a de-escalation strategy in well-lateralized tonsil cancers. The efficacy of this approach with multiple ipsilateral nodes is not established. The study hypothesis was that unilateral radiation for American Joint Committee on Cancer (AJCC)-7 T1-2N2b tonsillar cancer results in a low rate of contralateral nodal failure.

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Long-term results of ipsilateral radiotherapy for tonsil cancer. [2021] WE EVALUATED THE EFFECTIVENESS AND SAFETY OF IPSILATERAL RADIOTHERAPY FOR THE PATIENT WITH WELL LATERALIZED TONSIL CANCER: not cross midline and

7. United States pubmed.ncbi.nlm.nih.gov

The benefits and pitfalls of ipsilateral radiotherapy in carcinoma of the tonsillar region. [2019] Ipsilateral techniques designed to restrict treatment to the primary tumor and neck on the same side have been used in selected cases of cases of carcinoma of the tonsillar region at our institution for many years. The primary purpose of this study is to evaluate the risk of failure in the opposite neck in cases selected for unilateral radiotherapy over a 21-year period.

8. England pubmed.ncbi.nlm.nih.gov

Multiple cervical lymph node involvement and extra-capsular extension predict for contralateral nodal recurrence after ipsilateral radiotherapy for squamous cell carcinoma of the tonsil. [2022] Ipsilateral radiotherapy is an established technique for treating well-lateralised tonsillar tumours. Concerns exist regarding the risk of contralateral nodal failure, particularly in patients with ipsilateral nodal involvement at presentation. In this study, we retrospectively reviewed the clinical outcomes of patients treated with ipsilateral radiotherapy aiming to identify factors that predispose to a higher risk of contralateral nodal recurrence.