Radiation Therapy for Oropharyngeal Cancer

Not currently recruiting at 30 trial locations

Overseen By Steven J. Frank, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Must be taking: Chemotherapy

Disqualifiers: Pregnancy, Breastfeeding, Major cardiac disease, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6.5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of radiation therapy to determine which is more effective for treating advanced oropharyngeal cancer, a type of cancer in the throat area. One group will receive intensity-modulated photon therapy (Intensity-Modulated Radiation Therapy or IMRT), while the other will receive intensity-modulated proton beam therapy (IMPT). The researchers aim to discover if one method results in fewer side effects or is more effective at shrinking tumors. Individuals with stage III-IVB oropharyngeal cancer who can undergo chemotherapy and have not received certain head or neck radiation in the last five years might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, since concurrent chemotherapy is part of the treatment, it's best to discuss your current medications with the trial team to ensure there are no interactions.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both intensity-modulated proton beam therapy (IMPT) and intensity-modulated radiation therapy (IMRT) are safe for treating oropharyngeal cancer. Studies indicate that IMPT can lower the radiation dose to nearby organs, potentially reducing side effects. Patients who received proton therapy, such as IMPT, had a lower risk of dying from any cause, including cancer.

IMRT also demonstrates high survival rates and effectively prevents cancer from returning near the treated area. Comparisons of both therapies reveal similar safety and survival outcomes. Thus, both treatments are generally well-tolerated and are viable options for patients considering radiation therapy for oropharyngeal cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments for oropharyngeal cancer being explored because they utilize advanced radiation techniques, like Intensity-Modulated Proton Beam Therapy (IMPT) and Intensity-Modulated Radiation Therapy (IMRT), which offer more precise targeting of tumors. Unlike traditional radiation methods, IMPT uses protons instead of X-rays, potentially reducing damage to surrounding healthy tissue and minimizing side effects. IMRT, on the other hand, modulates the radiation dose to conform to the shape of the tumor, enhancing treatment precision. Both methods aim to improve patient outcomes by maximizing the dose delivered to cancer cells while sparing normal tissues, which is a significant advancement over standard radiation therapy options.

What evidence suggests that this trial's treatments could be effective for oropharyngeal cancer?

This trial will compare two treatments for oropharyngeal cancer: intensity-modulated proton beam therapy (IMPT) and intensity-modulated radiation therapy (IMRT). Research has shown that both IMPT and IMRT effectively treat oropharyngeal cancer. One study found that IMPT can lower the radiation dose to healthy organs, potentially reducing side effects while maintaining effectiveness. Another study showed that IMPT is as effective as IMRT in controlling cancer. For IMRT, research indicates a high two-year cancer-free rate of 96.8%. Both treatments are effective, but IMPT might result in fewer side effects. ^{1 2 3 6 7}

Who Is on the Research Team?

Steven J. Frank

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with stage III-IVB oropharyngeal cancer who can provide tumor tissue for testing. They should have an ECOG performance status of 0, 1, or 2 and be able to undergo concurrent chemotherapy and bilateral neck radiation. Pregnant women, those with recent heart issues, previous head and neck radiation within five years, distant metastases, uncontrolled major diseases or prior surgical resection for their cancer are excluded.

Inclusion Criteria

I am currently receiving chemotherapy.

My cancer is a type of throat cancer called squamous cell carcinoma.

My tumor can be tested for HPV or p16, or I can have a biopsy if needed.

Exclusion Criteria

Pregnant or breast-feeding females

I had radiation for head or neck cancer in the last 5 years.

I do not have uncontrolled heart, lung, kidney, liver, stomach, or blood diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either IMRT or IMPT once daily, five days a week for approximately 6.5 weeks

6.5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Every 3 months for 1 year, every 4 months for 1 year, then every 6 months for 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Intensity-Modulated Proton Beam Therapy (IMPT)
• Intensity-Modulated Radiation Therapy

Trial Overview

The study compares two types of radiation therapy: intensity-modulated proton beam therapy versus intensity-modulated photon therapy. It aims to determine which method is more effective in treating patients with advanced oropharyngeal cancer while also assessing side effects and impact on quality of life.

How Is the Trial Designed?

Group I: Arm II (IMPT) Experimental Treatment 4 Interventions

Patients undergo IMPT QD five days a week for approximately 6.5 weeks.

Group II: Arm I (IMRT) Experimental Treatment 4 Interventions

Patients undergo IMRT QD five days a week for approximately 6.5 weeks.

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+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

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 proton therapy (IMPT) for oropharyngeal carcinoma shows a potential reduction in severe weight loss and feeding tube dependency compared to intensity-modulated radiotherapy (IMRT), based on a study of 150 matched patients with a median follow-up of 32 months.

Despite these benefits, there were no significant differences in overall survival or progression-free survival between IMPT and IMRT, indicating that IMPT does not compromise treatment effectiveness while potentially improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated proton beam therapy (IMPT) versus intensity-modulated photon therapy (IMRT) for patients with oropharynx cancer - A case matched analysis. Blanchard, P., Garden, AS., Gunn, GB., et al.[2022]

Intensity-modulated proton therapy (IMPT) shows promise in treating HPV-associated oropharyngeal squamous cell carcinoma (OPC) by reducing side effects while maintaining effective treatment for the tumor, as it spares normal tissues from high radiation doses.

Retrospective studies indicate that IMPT results in lower rates of complications such as pain, dry mouth, and difficulty swallowing compared to traditional X-ray radiotherapy, which can significantly improve the quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Therapy for HPV-Associated Oropharyngeal Cancers of the Head and Neck: a De-Intensification Strategy. Taku, N., Wang, L., Garden, AS., et al.[2022]

In a study of 148 oropharynx cancer patients treated with either IMRT alone or a combination of IMRT and IMPT, the combination therapy showed significantly lower rates of severe acute toxicities, such as mucositis and pain, indicating a safer treatment option.

Despite similar overall survival and progression-free survival rates between the two groups, the IMRT/IMPT combination resulted in fewer patients experiencing grade ≥ 3 mucositis and pain, suggesting improved patient comfort during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Clinical Outcomes of Intensity Modulated Radiation Therapy/Intensity Modulated Proton Therapy Combination in Comparison with Intensity Modulated Radiation Therapy Alone in Oropharynx Cancer Patients. Yoon, HG., Ahn, YC., Oh, D., et al.[2021]

Patients with oropharyngeal carcinoma (OPC) treated with intensity-modulated proton therapy (IMPT) experienced significantly lower rates of acute toxic effects compared to those treated with intensity-modulated radiation therapy (IMRT), including less oral pain, xerostomia, and dysphagia.

Despite the reduced toxicity, both IMPT and IMRT showed similar oncologic outcomes, with 3-year overall survival rates of 97% for IMPT and 91% for IMRT, indicating that IMPT is a safer option without compromising treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity Profiles and Survival Outcomes Among Patients With Nonmetastatic Oropharyngeal Carcinoma Treated With Intensity-Modulated Proton Therapy vs Intensity-Modulated Radiation Therapy. Youssef, I., Yoon, J., Mohamed, N., et al.[2023]

Proton therapy (PT) for oropharyngeal carcinoma appears to improve quality of life (QOL) and patient-reported outcomes (PROs) compared to traditional photon-based therapy, particularly in areas like xerostomia (dry mouth) and appetite, based on a review of seven studies.

While PT shows benefits in reducing certain side effects, some issues like sexual symptoms did not improve as much, and overall, QOL and PROs did not fully return to baseline levels after treatment, indicating the need for further research on long-term effects and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life and Patient-Reported Outcomes Following Proton Therapy for Oropharyngeal Carcinoma: A Systematic Review. Yahya, N., Manan, HA.[2023]

Citations

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astro.org

astro.org/news-and-publications/news-and-media-center/news-releases/2025/imrt-matches-proton-therapy-in-patient-reported-outcomes-for

Intensity-modulated radiation therapy (IMRT) matches ...

At a median follow-up of 28.3 months, two-year freedom from cancer returning at or near the original tumor site was 94.3% for protons and 96.8% ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5474304/

Intensity modulated proton beam therapy (IMPT) versus ...

IMPT used for oropharyngeal carcinoma patients has the ability to reduce the dose to organs at risk compared to intensity-modulated radiotherapy (IMRT) while ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2331518023001993?via%3Dihub

Patient-Reported Outcomes after Intensity-Modulated ...

The dosimetric advantage of IMPT over IMRT has been well demonstrated, with studies showing reduction of dose to the oral cavity, swallowing structures, and ...

4.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.6006

Phase III randomized trial of intensity-modulated proton ...

IMPT is non-inferior to IMRT and has emerged as a standard of care CRT approach for OPC that reduces malnutrition and gastrostomy-tube dependence.

5.

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 ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0167814023898656

Comparing the oncologic outcomes of proton therapy and ...

Patients who received proton therapy had significantly lower risks of all-cause mortality (adjusted hazard ratio, aHR = 0.43), cancer-specific death (aHR = 0.44) ...

7.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1002/hed.27877

Efficacy and safety of proton therapy versus intensity‐ ...

Proton therapy demonstrated superior overall survival (OS), disease-free survival (DFS), and better local control rate (LCR) compared to IMRT.