Lymphoscintigraphy for Oropharyngeal Cancer

Overseen By David Rosenthal, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Previous HN cancer, Metastatic spread, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 6-8 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

To test a new radiation treatment design based on where your cancer is located. Most participants with oropharyngeal cancer are treated with radiation to both sides of the neck. However, for participants with oropharyngeal cancer on one side of the neck, receiving radiation to both sides of the neck may result in increased side effects and radiation exposure. This study is testing the safety and effectiveness of an approach that involves radiation to only one side of the neck in an effort to reduce the overall amount of radiation given and decrease the amount of side effects you may experience.

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 the treatment Ipsilateral Radiation, Unilateral Radiation, Single-Sided Radiation for oropharyngeal cancer?

Research shows that using unilateral (one-sided) radiation for well-lateralized oropharyngeal cancer can be effective, with low rates of cancer spreading to the opposite side of the neck. This approach is supported by studies that found low contralateral (opposite side) failure rates when treating oropharyngeal cancer with one-sided radiation. ^{1 2 3 4 5}

Is unilateral radiation therapy safe for humans?

Unilateral radiation therapy, including treatments like ipsilateral and single-sided radiation, has been studied for oropharyngeal cancer and is generally considered safe for well-selected patients. Studies show low rates of complications and reduced radiation-related side effects, making it a viable option for certain cases. ^{1 2 6 7 8}

How is the treatment Ipsilateral Radiation unique for oropharyngeal cancer?

Ipsilateral Radiation is unique because it targets only one side of the neck, reducing side effects like damage to the opposite side's salivary glands and throat tissue, while still effectively treating cancers that are well-lateralized (confined to one side). ^{1 5 9 10 11}

Research Team

David Rosenthal, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed HPV+ or p16+ oropharyngeal cancer that hasn't spread across the midline of the neck or to distant parts. Participants must be in good physical condition, able to understand and sign consent, and have no history of head/neck cancer (except minor skin cancers), previous radiation in that area, major surgeries like thyroidectomy, active pregnancy without contraception, iodine allergy, or certain autoimmune diseases.

Inclusion Criteria

My breast cancer is in an early stage, not widely spread.

I am older than 18 years.

I can undergo a lymph node mapping procedure.

Exclusion Criteria

I have had cancer that spread beyond its original location.

My cancer has spread to distant parts of my body.

I have had surgery to remove my thyroid or lymph nodes in my neck.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ipsilateral radiation therapy or surgery for oropharyngeal cancer

Approximately 6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Ipsilateral Radiation

Trial Overview The study tests a new radiation treatment targeting only one side of the neck instead of both sides for people with one-sided oropharyngeal cancer. The goal is to see if this approach can effectively treat cancer while reducing side effects and overall radiation exposure compared to traditional methods.

Participant Groups

Group I: Arm 1- Ipsilateral Experimental Treatment 1 Intervention

Participants with ipsilateral-only drainage (Arm 1- Ipsilateral) will be randomized to assign definitive ipsilateral RT (without concurrent chemotherapy) -vs- ipsilateral surgery (TORS/ND).

Ipsilateral Radiation is already approved in United States, European Union for the following indications:

Approved in United States as Ipsilateral Radiation for:

• Oropharyngeal cancer

Approved in European Union as Unilateral Radiation for:

• Head and neck cancers
• Oropharyngeal neoplasms

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

In a study of 37 patients with advanced-stage oropharyngeal cancer, unilateral radiotherapy (RT) resulted in a high 3-year locoregional control rate of 96%, indicating its efficacy for this treatment approach.

The study showed low rates of contralateral neck failure and maintained tolerances for surrounding organs, with patients reporting low to moderate distress levels during treatment, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low rates of contralateral neck failure in unilaterally treated oropharyngeal squamous cell carcinoma with prospectively defined criteria of lateralization. Hu, KS., Mourad, WF., Gamez, M., et al.[2018]

In a study of 185 patients with well-lateralized oropharyngeal cancer treated with unilateral neck IMRT, the 5-year regional control rate was an impressive 96%, indicating effective treatment outcomes.

The treatment had a favorable toxicity profile, with only 2.2% experiencing grade 3 late toxicity and no patients dependent on feeding tubes six weeks post-treatment, suggesting a safe approach for managing this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unilateral neck irradiation for well-lateralized oropharyngeal cancer. Al-Mamgani, A., van Rooij, P., Fransen, D., et al.[2013]

In a study of 32 patients with lateralized oropharyngeal carcinoma treated with transoral robotic surgery (TORS) and unilateral neck management, the 3-year contralateral regional control rate was 100%, indicating no significant risk of contralateral nodal failure.

The overall survival and local control rates were both 96%, suggesting that this treatment approach is effective and oncologically safe for selected patients with this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contralateral nodal failures in oropharyngeal cancers after TORS and unilateral neck management: a retrospective study. Sahovaler, A., Lee, JJW., Xu, W., et al.[2022]

In a study of 25 patients with p16-positive squamous cell carcinoma of unknown primary origin, targeted ipsilateral irradiation of the oropharynx resulted in high rates of disease control, with 2-year overall survival at 92%.

The treatment was well-tolerated, showing no severe toxicity (grade 3 or higher), indicating that this focused radiation approach may be safer than traditional comprehensive radiation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oropharynx-directed ipsilateral irradiation for p16-positive squamous cell carcinoma involving the cervical lymph nodes of unknown primary origin. Chen, AM., Meshman, J., Hsu, S., et al.[2019]

In a study of 61 patients with node-positive squamous cell carcinoma of the tonsil, treatment with ipsilateral neck radiotherapy resulted in a 5-year overall survival rate of 92.4% and a disease-free survival rate of 86.7%.

The risk of contralateral nodal failure was extremely low at 2%, suggesting that patients with well-lateralized tonsil cancers may not require prophylactic radiation to the opposite side of the neck.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Freedom from local and regional failure of contralateral neck with ipsilateral neck radiotherapy for node-positive tonsil cancer: updated results of an institutional clinical management approach. Dan, TD., Raben, D., Schneider, CJ., et al.[2015]

A review of 11 studies involving 1116 patients with head and neck squamous cell carcinoma (HNSCC) found that the incidence of contralateral regional failure (cRF) is very low (2.4%) when treating oropharyngeal cancer with unilateral neck irradiation, suggesting that many patients may be overtreated.

For patients with lateralized tumors that do not cross the midline, a more selective approach to unilateral elective nodal irradiation could reduce unnecessary radiation exposure and improve quality of life, supported by advancements in diagnostic imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elective unilateral nodal irradiation in head and neck squamous cell carcinoma: A paradigm shift. Al-Mamgani, A., Verheij, M., van den Brekel, MWM.[2022]

Ipsilateral radiotherapy for well lateralized tonsil cancer showed high effectiveness, with a five-year local progression-free survival rate of 95% and an overall survival rate of 95% among 20 patients followed for a median of 64 months.

The treatment resulted in a low incidence of chronic xerostomia (dry mouth), with only one patient experiencing grade 2 xerostomia, indicating that this approach can minimize side effects by sparing the contralateral salivary glands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of ipsilateral radiotherapy for tonsil cancer. Koo, TR., Wu, HG.[2021]

In a study of 41 patients with oropharyngeal squamous cell carcinoma treated with unilateral proton beam therapy (PBT), the contralateral neck failure rate was very low at 2.4%, indicating effective control of the disease in the treated area.

The 1-year locoregional control rate was 88.9%, and the treatment was associated with manageable toxicity, with only 20% of patients experiencing grade 3 dysphagia or esophagitis, and no severe toxicities (grade ≥ 4) reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low contralateral failure rate with unilateral proton beam radiotherapy for oropharyngeal squamous cell carcinoma: A multi-institutional prospective study from the proton collaborative group. Mumaw, DA., Hazy, AJ., Vayntraub, A., et al.[2023]

Ipsilateral radiation treatment for tonsil carcinoma resulted in a 5-year disease-specific survival rate of 61% and a primary tumor control rate of 75%, with even higher control rates (84%) for smaller tumors (T1 and T2).

This approach not only reduces acute radiation reactions and late damage to contralateral salivary tissue but also shows a low risk of nodal recurrence in the contralateral neck, making it a safer alternative to bilateral radiation treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer of the tonsil: the results of ipsilateral radiation treatment. Jackson, SM., Hay, JH., Flores, AD., et al.[2019]

In a study of 66 patients with AJCC-7 T1-2N2b tonsillar cancer treated with unilateral radiation, the contralateral nodal failure rate was very low at only 3.0%, indicating that this treatment strategy is effective for managing multiple ipsilateral nodes.

The overall locoregional control rate was high at 93.9% over 2 and 5 years, with a 5-year overall survival rate of 92.4%, suggesting that unilateral radiation is a safe and effective de-escalation strategy for this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Locoregional Control With Unilateral Radiation for AJCC-7 T1-2N2b Tonsillar Cancer. Frankart, AJ., Abana, CO., Geier, N., et al.[2023]

In a study of 20 patients with node-positive squamous cell carcinoma of the tonsil, treatment with ipsilateral neck radiotherapy showed no cases of in-field or contralateral nodal recurrences at a median follow-up of 19 months, indicating effective local control of the disease.

The treatment resulted in a 2-year disease-free survival rate of 79.5% and low late toxicity, with only 5% of patients experiencing grade 2 xerostomia, suggesting that this approach may reduce long-term side effects compared to traditional methods.

NCBI (Pubmed)

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. Rusthoven, KE., Raben, D., Schneider, C., et al.[2009]

References

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

Low rates of contralateral neck failure in unilaterally treated oropharyngeal squamous cell carcinoma with prospectively defined criteria of lateralization. [2018]

2. Ireland pubmed.ncbi.nlm.nih.gov

Unilateral neck irradiation for well-lateralized oropharyngeal cancer. [2013]

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

Contralateral nodal failures in oropharyngeal cancers after TORS and unilateral neck management: a retrospective study. [2022]

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

Oropharynx-directed ipsilateral irradiation for p16-positive squamous cell carcinoma involving the cervical lymph nodes of unknown primary origin. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Freedom from local and regional failure of contralateral neck with ipsilateral neck radiotherapy for node-positive tonsil cancer: updated results of an institutional clinical management approach. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Elective unilateral nodal irradiation in head and neck squamous cell carcinoma: A paradigm shift. [2022]

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

Long-term results of ipsilateral radiotherapy for tonsil cancer. [2021]

8. Ireland pubmed.ncbi.nlm.nih.gov

Low contralateral failure rate with unilateral proton beam radiotherapy for oropharyngeal squamous cell carcinoma: A multi-institutional prospective study from the proton collaborative group. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

Cancer of the tonsil: the results of ipsilateral radiation treatment. [2019]

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

Long-term Locoregional Control With Unilateral Radiation for AJCC-7 T1-2N2b Tonsillar Cancer. [2023]

11. 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]