MRI-Guided Radiotherapy for Oropharyngeal Cancer

Overseen By Clifton Fuller, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Major cardiac disease, 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

Compensation: Varies

Number of Visits: 34

Duration: 6.5 weeks

90 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

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 MRI-Guided Radiotherapy for Oropharyngeal Cancer?

Research shows that intensity-modulated radiotherapy (IMRT) is effective for treating oropharyngeal cancer by reducing side effects like dry mouth while maintaining good control over the tumor. MRI guidance can potentially improve the precision of IMRT, making it even more effective by better targeting the cancer and sparing healthy tissue. ^{1 2 3 4 5}

Is MRI-guided radiotherapy safe for humans?

Research on intensity-modulated radiotherapy (IMRT), which is similar to MRI-guided radiotherapy, shows that it is generally safe for treating oropharyngeal cancer. It reduces side effects like dry mouth compared to older methods, while still effectively targeting the cancer. ^{1 2 3 6 7}

How is MRI-Guided IMRT different from other treatments for oropharyngeal cancer?

MRI-Guided IMRT is unique because it uses MRI (magnetic resonance imaging) to precisely guide the delivery of radiation, allowing for better targeting of the cancer while sparing healthy tissue. This approach can reduce side effects like dry mouth and improve tumor control compared to conventional radiation techniques. ^{1 2 3 4 8}

What is the purpose of this trial?

The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer. This is an investigational study. MRI simulations and radiation therapy are delivered using FDA-approved and commercially available methods. The use of MRI imaging to plan the dose is investigational. Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.

Research Team

Clifton D. Fuller

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with HPV-positive oropharyngeal cancer, who haven't had major head and neck surgery or other treatments for it. They should have a light smoking history (less than 10 pack-years) and not currently smoke. Participants need to be in decent health overall, able to understand the study, and women must not be pregnant.

Inclusion Criteria

I smoked less than 10 pack-years and quit over 5 years ago.

No retropharyngeal nor level IV (or lower) lymphadenopathy

I am set to receive photon/proton radiotherapy, with or without chemotherapy.

Exclusion Criteria

Contraindications to MR imaging per institutional policy on management of patients with internal and external medical devices

I do not have any uncontrolled major health issues.

My kidney function is reduced with a GFR less than 40.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Visit

Participants undergo various baseline assessments including hearing test, dental exam, swallowing function test, and questionnaires

1 day

1 visit (in-person)

Treatment

Participants receive radiation therapy 5 days a week for up to 6 ½ weeks, with weekly assessments and MRI simulations for some groups

6.5 weeks

33 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 weeks, 6 months, 1 year, 2 years, and 5 years

5 years

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Intensity Modulated Radiotherapy (IMRT)
• MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning
• Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Planning

Trial Overview The study compares MRI-guided IMRT planning with standard IMRT doses in treating low-risk HPV-positive oropharyngeal cancer. The goal is to see if MRI can better tailor radiation doses. All methods are FDA-approved; using MRI this way is investigational.

Participant Groups

Group I: MRI Guided Intensity Modulated Radiotherapy (IMRT) Experimental Treatment 6 Interventions

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy. Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Group II: Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Active Control 6 Interventions

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy. Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Intensity-modulated radiotherapy (IMRT) for oropharyngeal squamous cell carcinoma showed promising 5-year local control rates, with 87% overall and varying by cancer stage, indicating its efficacy in managing advanced disease.

The treatment resulted in a 5-year cause-specific survival rate of 85% and an overall survival rate of 76%, with a relatively low incidence of severe late complications (8%), suggesting that IMRT is a safe and effective option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy for oropharyngeal squamous cell carcinoma. Mendenhall, WM., Amdur, RJ., Morris, CG., et al.[2022]

Intensity modulated radiation treatment (IMRT) for oropharyngeal squamous cell carcinoma showed excellent locoregional control, with a 3-year locoregional progression-free survival rate of 98.8% among 66 patients treated between 2000 and 2004.

Despite the high locoregional control, there was a concerning rate of distant metastasis, with a 3-year distant metastasis-free survival rate of only 80.4%, indicating a need for further research into systemic treatments for patients at risk of distant disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing failure patterns in oropharyngeal squamous cell carcinoma treated with intensity modulated radiotherapy and implications for future research. Yao, M., Nguyen, T., Buatti, JM., et al.[2006]

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]

Both MV-kV and CBCT imaging modalities produced similar setup error measurements for head-and-neck cancer patients, indicating that either method can be effectively used for image-guided radiation therapy.

MV-kV imaging was significantly faster and delivered a lower radiation dose (6.88 mGy) compared to CBCT (17.2 mGy), suggesting it could be a suitable alternative when reduced imaging time is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Setup margin for head-and-neck cancer patients receiving 2D-2D and 3D image-guided intensity-modulated radiation therapy]. Kovács, P., Szita, E., Schvarcz, K., et al.[2018]

Intensity-modulated radiation therapy (IMRT) significantly reduces the incidence of severe xerostomia (dry mouth) in patients with head and neck cancer compared to traditional 2D and 3D radiation therapies, as shown in a review of five randomized trials involving 871 patients.

IMRT provides these benefits without compromising loco-regional control or overall survival rates, indicating it is a safer and more effective option for managing head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy for head and neck cancer: systematic review and meta-analysis. Marta, GN., Silva, V., de Andrade Carvalho, H., et al.[2022]

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]

References

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

Intensity-modulated radiotherapy for oropharyngeal squamous cell carcinoma. [2022]

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

Changing failure patterns in oropharyngeal squamous cell carcinoma treated with intensity modulated radiotherapy and implications for future research. [2006]

3. 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]

4. Hungary pubmed.ncbi.nlm.nih.gov

[Setup margin for head-and-neck cancer patients receiving 2D-2D and 3D image-guided intensity-modulated radiation therapy]. [2018]

5. Ireland pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy for head and neck cancer: systematic review and meta-analysis. [2022]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of intensity-modulated radiotherapy in oropharyngeal cancer. [2012]

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

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