Radiotherapy Techniques for Oropharyngeal Cancer

Overseen By Tuvara King

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Sjogren's syndrome, Baseline xerostomia, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to reduce dry mouth in individuals with oropharyngeal cancer undergoing radiation therapy. It compares standard radiotherapy with an experimental approach that uses MRI (magnetic resonance imaging) to better target treatment and spare parts of the salivary glands. The aim is to lessen dry mouth severity, improving comfort and quality of life after treatment. Individuals with oropharyngeal cancer and no history of dry mouth or radiation to the head and neck may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could enhance patient comfort and quality of life.

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 investigators to get a clear answer.

What prior data suggests that these radiotherapy techniques are safe for oropharyngeal cancer patients?

Research has shown that radiation therapy for head and neck cancer can cause side effects like dry mouth, or xerostomia, which can persist and affect quality of life. One study found that adjusting radiation to protect the salivary glands reduced the incidence of dry mouth.

For those considering joining a trial, understanding the safety of these treatments is crucial. Studies have indicated that with intensity-modulated radiation therapy (IMRT), severe dry mouth occurred in about 1.3% of cases. Other common side effects included skin irritation in 19% of participants and a sore mouth or throat in 32%.

Overall, while some side effects may occur, they are usually not severe. The adjustments being tested aim to make these treatments safer and more comfortable for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these radiotherapy techniques for oropharyngeal cancer because they aim to protect the salivary glands better than standard methods. The experimental approach uses magnetic resonance imaging (MRI) to precisely locate the parotid ducts, allowing doctors to limit the radiation dose to these sensitive structures to no more than 14 Gy. This precision could help preserve salivary gland function, potentially reducing side effects like dry mouth, which is common with standard radiotherapy. By focusing on sparing these key areas, the techniques might improve patients' quality of life during and after treatment.

What evidence suggests that this trial's radiotherapy techniques could be effective for reducing xerostomia in oropharyngeal cancer patients?

This trial will compare different radiotherapy techniques for oropharyngeal cancer. Research has shown that new methods of delivering radiotherapy, such as intensity-modulated radiotherapy (IMRT), hold promise for treating oropharyngeal cancer. These techniques have resulted in survival rates of 60% to 75% over five years and better control of cancer in the treated area. In this trial, one arm will use MRI to guide radiation away from sensitive areas, like the salivary glands, to reduce dry mouth, a common side effect. This approach focuses on protecting the stem cells in these areas, potentially improving patients' quality of life by lessening dry mouth. Meanwhile, the other arm will use standard radiotherapy planning to restrict the mean parotid radiation dose. ^{6 7 8 9 10}

Who Is on the Research Team?

Colette Shen

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with dry mouth due to radiation treatment for cancers in the throat or head and neck area. Participants must have a diagnosis of oropharyngeal cancer and be scheduled to receive radiotherapy.

Inclusion Criteria

Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information

I am willing and able to follow the study's requirements.

My throat cancer is at a stage where it can be treated with radiation, with or without chemotherapy.

Exclusion Criteria

Patients with an allergy to lemon juice

I have had radiation therapy to my head or neck before.

I have Sjogren's syndrome or I often have a very dry mouth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive MRI-guided radiation therapy to spare parotid ducts and reduce xerostomia

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of xerostomia and saliva production

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Experimental Radiotherapy
• Standard Radiotherapy

Trial Overview The study compares standard radiotherapy with an experimental approach that uses MRI to try sparing parts of the salivary glands during treatment, aiming to reduce dry mouth symptoms after therapy.

How Is the Trial Designed?

Group I: Parotid Duct Experimental Treatment 1 Intervention

Magnetic resonance images will be used to localize the parotid ducts and limit the radiation dose to these structures to less than or equal to 14 Gy.

Group II: Mean Parotid Active Control 1 Intervention

Standard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Published Research Related to This Trial

Intensity-modulated radiation therapy (IMRT) significantly reduced the incidence of late xerostomia (dry mouth) in patients with oropharyngeal cancer compared to conventional radiation therapy (CRT), indicating a safety advantage for IMRT.

The study, which followed 430 patients over a median of 3.9 years, found that IMRT did not negatively affect tumor control or disease-free survival rates, demonstrating its efficacy in treating oropharyngeal carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy reduces late salivary toxicity without compromising tumor control in patients with oropharyngeal carcinoma: a comparison with conventional techniques. Chao, KS., Majhail, N., Huang, CJ., et al.[2022]

Modern radiation therapy, particularly intensity-modulated radiation therapy (IMRT), significantly reduces xerostomia (dry mouth) and improves the quality of life for patients with oropharyngeal cancer.

Intensity-modulated proton therapy may offer even greater benefits by minimizing radiation-related toxicities, which is crucial for patients with HPV-positive oropharyngeal carcinoma who are likely to have long-term survival after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in radiation oncology for the management of oropharyngeal tumors. Gunn, GB., Frank, SJ.[2018]

In a study of 139 oropharyngeal cancer patients, those treated with an ipsilateral radiotherapy technique experienced significantly reduced side effects, such as xerostomia and dysphagia, compared to those receiving bilateral treatment.

The ipsilateral treatment did not negatively impact loco-regional control or survival rates, making it a safe option for selected patients with localized tonsillar cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity after ipsilateral radiotherapy for oropharyngeal cancer. Jensen, K., Overgaard, M., Grau, C.[2007]

Intensity-modulated radiotherapy (IMRT) shows excellent local-regional control rates of 92% for patients with squamous cell carcinoma of the oropharynx, based on a study of 107 patients with a median follow-up of 29 months.

Despite the high local control, distant metastases were a significant concern, with 7 patients experiencing them as the first site of failure, highlighting the need for ongoing monitoring and potential additional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy in the treatment of oropharyngeal cancer: clinical outcomes and patterns of failure. Daly, ME., Le, QT., Maxim, PG., et al.[2022]

Intensity-modulated radiation therapy (IMRT) can significantly reduce the amount of mucosal tissue exposed to high radiation doses in patients with early oropharyngeal cancer, especially when a dose objective is set for the mucosa.

In a study involving 5 patients, IMRT with a mucosal dose objective resulted in up to a 30% reduction in mucosal exposure to high doses compared to standard three-field technique (3FT) radiotherapy, indicating that IMRT may offer a safer treatment option with less risk of damaging healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a "mucosa-sparing" benefit of IMRT for head-and-neck cancer? Sanguineti, G., Endres, EJ., Gunn, BG., et al.[2006]

Patients with HPV+ oropharyngeal squamous cell carcinoma show significantly improved overall survival and disease-specific survival when treated with platinum-based chemotherapy combined with radiotherapy, as indicated by a meta-analysis of 1130 patients from nine ongoing randomized controlled trials.

One trial suggests that using the EGFR inhibitor cetuximab may lead to reduced survival outcomes in HPV+ patients, highlighting the need for careful consideration of treatment protocols in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De-escalation treatment protocols for human papillomavirus-associated oropharyngeal squamous cell carcinoma: a systematic review and meta-analysis of current clinical trials. Masterson, L., Moualed, D., Liu, ZW., et al.[2023]

In a study comparing 26 patients receiving radiotherapy with cetuximab (cet-RT) to 27 patients receiving chemotherapy (chemo-RT) for HPV+ oropharyngeal cancer, both groups showed similar functional outcomes and quality of life over time, despite some initial worsening in swallowing and quality of life scores.

The results suggest that using cetuximab instead of chemotherapy for treatment de-intensification in HPV+ oropharyngeal cancer may not provide significant advantages, as both treatment approaches yielded excellent clinical outcomes without notable differences in patient functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparisons of dysphagia and quality of life (QOL) in comparable patients with HPV-positive oropharyngeal cancer receiving chemo-irradiation or cetuximab-irradiation. Samuels, SE., Tao, Y., Lyden, T., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12287490/

Advances in radiotherapy for mouth neoplasms Intensity-modulated radiotherapy, for example, has demonstrated 5-year overall survival rates ranging from 60 to 75%, with better local control ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772906024005053

Combining radiotherapy and systemic therapies in ... The integration of systemic therapies with radiotherapy has markedly enhanced survival outcomes for patients with oropharyngeal cancer (OPC). Clinical evidence ...

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1272856/full

Outcomes among oropharyngeal and oral cavity cancer ... We also found that oral cavity cancers generally had poorer outcomes than oropharyngeal cancers, with 2-year LC rates of 85.1% vs 96.7% (p=0.031) ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2798320

Toxicity Profiles and Survival Outcomes Among Patients ... This cohort study compares the toxic effects and oncologic outcomes associated with intensity-modulated radiation therapy (IMRT) vs ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825000400

Adaptive radiotherapy for oropharyngeal cancer with daily ... Data of 34 consecutive patients treated from September 2022 to May 2024 at a single Institution with RCHT on Unity® MR-linac for OPSCC with daily adaptive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9652753/

Toxicity Profiles and Survival Outcomes Among Patients ... This cohort study compares the toxic effects and oncologic outcomes associated with intensity-modulated radiation therapy (IMRT) vs intensity-modulated proton ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11906207/

Toxicity and Oncologic Outcomes of Proton Radiotherapy ... Pooled rates of acute grade 3+ toxicities were as follows: dermatitis 19%, mucositis 32%, xerostomia 1.3%, dysphagia 13%, and weight loss 1.4%.

8. nature.com nature.com/articles/s44276-025-00164-z

Long-term outcomes of consecutive patients ... The five-year LC, LRC, DFS and OS rates were 84%, 71% 64%, 69% in HPV-positive patients and 44%, 32%, 26% and 32% in HPV-negative patients, ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S245210942500185X

Efficacy and Toxicity of Simultaneous modulated ... Results. Twenty-seven patients completed 80% of the planned radiotherapy treatment (≥20 fractions) while 87% of patients received concurrent ...

10. nrgoncology.org nrgoncology.org/Home/News/Post/reduced-dose-radiation-with-cisplatin-improves-outcomes-for-hpv-associated-oropharyngeal-carcinoma-patients-on-nrg-oncology-study-justifies-phase-iii-trial

Reduced-Dose Radiation with Cisplatin Improves Outcomes f Data indicated that the IMRT+C arm yielded a 2-year PFS rate of 90.5% (p=0.04, rejecting the null hypothesis of 2-year PFS ≤ 85%) compared to ...