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

98 Participants Needed

Trial Summary

What is the purpose of this trial?

Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment. This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.

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 data supports the effectiveness of radiotherapy techniques for oropharyngeal cancer?

Research shows that radiotherapy, whether combined with chemotherapy or cetuximab (a targeted therapy), can be effective for treating oropharyngeal cancer, especially in patients with HPV-related cancer. Studies also compare different radiotherapy techniques, like concomitant boost radiotherapy, to assess their effectiveness and side effects, indicating that radiotherapy is a viable treatment option for this type of cancer. ^{1 2 3 4 5}

Is radiotherapy for oropharyngeal cancer safe for humans?

Radiotherapy for oropharyngeal cancer can cause severe side effects, but modern techniques like intensity-modulated radiotherapy (IMRT) aim to reduce these effects and improve quality of life. However, both acute (short-term) and chronic (long-term) side effects are still possible, so safety varies depending on the specific method and patient condition. ^{6 7 8 9 10}

How does experimental radiotherapy differ from standard radiotherapy for oropharyngeal cancer?

Experimental radiotherapy, such as intensity-modulated radiation therapy (IMRT), is designed to better target the cancer while sparing healthy tissue, potentially reducing side effects like salivary gland damage compared to standard radiotherapy techniques. ^{11 12 13 14 15}

Research Team

Colette Shen

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

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 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England 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. [2018]

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

Comparison of concomitant boost radiotherapy against concurrent chemoradiation in locally advanced oropharyngeal cancers: a phase III randomised trial. [2013]

3. Spain pubmed.ncbi.nlm.nih.gov

Results of radiotherapy in oropharyngeal carcinomas. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Transoral Surgery or Radiotherapy for Oropharyngeal Carcinoma - Is It Either Or…? [2018]

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

The impact of treatment modality and radiation technique on outcomes and toxicity of patients with locally advanced oropharyngeal cancer. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Morbidity after ipsilateral radiotherapy for oropharyngeal cancer. [2007]

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

Intensity-modulated radiotherapy in the treatment of oropharyngeal cancer: clinical outcomes and patterns of failure. [2022]

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

The role of brachytherapy in the management of oropharyngeal carcinomas: the Trento experience. [2022]

9. England 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. [2023]

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

Advances in radiation oncology for the management of oropharyngeal tumors. [2018]

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

Neoadjuvant chemotherapy followed by concurrent hyperfractionated radiation therapy and sensitizing chemotherapy for locally advanced (T3-T4) oropharyngeal squamous cell carcinoma. [2018]

12. Ireland 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. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

[Results of radiologic and combined surgical and radiologic treatment of oropharyngeal carcinomas (author's transl)]. [2006]

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

Is there a "mucosa-sparing" benefit of IMRT for head-and-neck cancer? [2006]

15. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Topometric and clinico-dosimetric aspects of the radiotherapy of cancer of the oropharynx]. [2006]