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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using MRI scans to plan radiation therapy for HPV-positive oropharyngeal cancer is more effective than the usual method. It compares two approaches: one with MRI guidance and another with the standard planning method for radiation treatment. Suitable participants have been diagnosed with HPV-positive oropharyngeal cancer, have not smoked in over five years, and have not undergone major surgery or treatment for this cancer before. MD Anderson will treat and monitor participants over several years to assess the treatment's effectiveness and side effects. As a Phase 2 trial, the research focuses on evaluating the treatment's efficacy in an initial, smaller group of people.

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 prior data suggests that MRI-guided radiotherapy planning is safe for oropharyngeal cancer patients?

Research shows that intensity modulated radiotherapy (IMRT) is generally safe for treating oropharyngeal cancer. In past studies, patients tolerated IMRT well, with manageable side effects. A common side effect was dry mouth, but it was usually not severe.

MRI-guided IMRT is similar to regular IMRT, with the addition of MRI for planning the radiation dose, which the researchers are investigating. This method might target the cancer more precisely, potentially reducing side effects. Although detailed safety data for MRI-guided IMRT is limited, the FDA's approval of IMRT for oropharyngeal cancer suggests its safety.

In summary, this trial uses a well-tolerated treatment, enhanced by the precision of MRI guidance. Safety data from previous IMRT studies provides reassurance about its use in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI Guided Intensity Modulated Radiotherapy (IMRT) for oropharyngeal cancer because it offers more precise targeting of tumors compared to standard IMRT. This MRI-guided approach allows for real-time imaging, helping to better focus radiation on cancer cells while sparing healthy tissue. By potentially reducing damage to surrounding healthy tissues, this method may lead to fewer side effects and improved quality of life for patients. Additionally, the personalized dosing based on MRI guidance could enhance the effectiveness of the treatment, offering a promising advancement over traditional radiotherapy techniques.

What evidence suggests that MRI-guided IMRT planning could be effective for oropharyngeal cancer?

Research shows that intensity-modulated radiotherapy (IMRT) effectively treats oropharyngeal cancer, which affects the throat area. Studies have found that IMRT achieves good long-term results, with about 87% of patients having their cancer well-controlled in the treated area over five years. This trial will compare two approaches: MRI Guided Intensity Modulated Radiotherapy (IMRT) and Standard-of-Care Intensity Modulated Radiotherapy (IMRT). Researchers aim to use MRI scans to guide IMRT, potentially making the treatment more precise by better targeting the tumor. Early findings suggest that using MRI can adjust the treatment to fit the tumor's shape and size each day, possibly leading to better results. This method might reduce side effects and improve survival rates, but more research is needed to confirm these benefits. ^{3 6 7 8 9}

Who Is on the Research Team?

Clifton D. Fuller

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6791404/

Ten-Year Outcomes Of Intensity-Modulated Radiotherapy ... Patients with stage II NPC who are treated with IMRT may obtain satisfactory long-term survival outcomes. The additional chemotherapy cannot significantly ...

2. withpower.com withpower.com/trial/phase-3-oropharyngeal-neoplasms-2018-ac705

MRI-Guided Radiotherapy for Oropharyngeal Cancer Intensity-modulated radiotherapy (IMRT) for oropharyngeal squamous cell carcinoma showed promising 5-year local control rates, with 87% overall and varying by ...

3. 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 ...

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. link.springer.com link.springer.com/article/10.1007/s42399-023-01562-5

Clinical Efficacy and Complications of Intensity-modulated ... We explored the relative clinical efficacy of intensity-modulated radiation therapy (IMRT) in patients with oropharyngeal cancer (OPC) compared

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. sciencedirect.com sciencedirect.com/science/article/pii/S240563082100094X

A Phase I safety and feasibility trial of MRI-guided adaptive ... Fuller, A.S. Mohamed, et al. Clinical outcomes and patterns of disease recurrence after intensity modulated proton therapy for oropharyngeal squamous carcinoma.

8. withpower.com withpower.com/trial/phase-3-oropharyngeal-neoplasms-2018-ac705?lat=34.60184&lng=-117.81218

MRI-Guided Radiotherapy for Oropharyngeal Cancer Research on intensity-modulated radiotherapy (IMRT), which is similar to MRI-guided radiotherapy, shows that it is generally safe for treating oropharyngeal ...

9. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2805682

Weekly Adaptive Radiotherapy vs Standard Intensity ... Importance Xerostomia is a major toxic effect associated with intensity-modulated radiotherapy (IMRT) for oropharyngeal cancers. · Objective ...