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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering radiation treatment for oropharyngeal cancer (a type of throat cancer) located on one side of the neck. Typically, radiation targets both sides, which can increase side effects. The study tests whether targeting only the affected side, known as ipsilateral radiation, can be safer while remaining effective. Suitable participants have newly diagnosed oropharyngeal cancer on one side of the neck, confirmed by tests, with no spread to the other side. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to advance cancer care.

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 prior data suggests that this radiation treatment design is safe?

Research has shown that treating only one side of the neck with radiation is generally safe for patients with oropharyngeal cancer. Studies have found that focusing radiation on just one side can reduce side effects while maintaining effectiveness. Specifically, patients experience fewer harmful effects when only one side of the neck is targeted, compared to treating both sides.

Patients also report less severe symptoms related to radiation when only one side is treated. This method helps manage overall side effects and limits unnecessary radiation exposure. Overall, these findings suggest that treating one side of the neck with radiation is a well-tolerated option for those with cancer on one side. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for oropharyngeal cancer?

Researchers are excited about the use of ipsilateral radiation for oropharyngeal cancer because it offers a more targeted approach, focusing only on the affected side of the neck. Unlike the standard treatments, which often involve bilateral radiation or chemotherapy that affects both sides of the neck, this method aims to minimize exposure and potential side effects. By potentially reducing the impact on healthy tissue, ipsilateral radiation could lead to fewer complications and a better quality of life for patients. This precision in treatment is a key reason why it's generating interest in the medical community.

What evidence suggests that ipsilateral radiation might be an effective treatment for oropharyngeal cancer?

Research has shown that targeting only one side of the neck with radiation, known as ipsilateral radiation, can effectively treat oropharyngeal cancer while reducing side effects. In this trial, participants with ipsilateral-only drainage will be randomized to receive either definitive ipsilateral radiation therapy (RT) without concurrent chemotherapy or ipsilateral surgery (TORS/ND). Studies indicate a low risk of cancer spreading to the untreated side of the neck with this method.

For patients with small tonsil cancers located on one side, using radiation on just that side, called unilateral radiation, is both safe and effective. By focusing radiation only on the affected side, patients may experience fewer immediate and long-term side effects compared to more traditional, intensive radiation treatments. This approach aims to maintain treatment effectiveness while reducing unnecessary radiation exposure. ^{1 5 6 7 8}

Who Is on the Research Team?

David Rosenthal, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 surgery to remove my thyroid or lymph nodes in my neck.

I have had cancer that spread beyond its original location.

My cancer has spread to distant parts of my body.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10330681/

Association of Ipsilateral Radiation Therapy with Contralateral ... In this systematic review and meta-analysis, we evaluated the rate of CNF after ipsilateral RT for OCSCC. This is an important endpoint given that salvage ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625061887

A Population-Based Cohort Study Using the Swedish Head ... Despite their improved outcomes, patients remain labored with the acute and late side effects of treatment from intensive courses of radiation ...

3. practicalradonc.org practicalradonc.org/article/S1879-8500(24)00139-5/fulltext

Radiation Therapy for HPV-Positive Oropharyngeal ... For most patients with oropharyngeal cancer, a mean dose <2000 cGy in the ipsilateral or node-positive neck and dose <500 cGy in the ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2801100

Association of Unilateral Radiotherapy With Contralateral ... In this systematic review and meta-analysis, ipsilateral neck RT was associated with a low rate of CNF in patients with small, lateralized tonsil cancers.

5. e-roj.org e-roj.org/m/journal/view.php?number=1606

Unilateral radiotherapy for tonsillar cancer with multiple ... The results of our study suggest that unilateral RT can be safely performed in well-lateralized tonsillar cancer patients with multiple ipsilateral neck lymph ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814025045530

Unilateral vs bilateral neck irradiation: The importance of ... This matched analysis supports its safety in well-selected patients. Unilateral radiotherapy reduces treatment-related toxicities.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9128573/

IPSILATERAL RADIATION FOR SQUAMOUS CELL ... Favorable oropharynx cancer survival rates led to increasing appreciation of toxicities associated with therapy. One way to potentially address toxicity is to ...

8. redjournal.org redjournal.org/article/S0360-3016(22)03389-2/fulltext

Patient-Reported Outcomes After Unilateral Treatment for ... The primary outcome of the study was the 2-year “radiation symptom severity score,” a metric created by the authors that combines scores from 9 ...