Radiation Therapy for Oropharyngeal Cancer

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

440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized phase III trial studies the side effects and how well intensity-modulated proton beam therapy works and compares it to intensity-modulated photon therapy in treating patients with stage III-IVB oropharyngeal cancer. Radiation therapy uses high-energy x-rays, protons, and other types of radiation to kill tumor cells and shrink tumors. It is not yet known whether intensity-modulated proton beam therapy is more effective than intensity-modulated photon therapy in treating oropharyngeal cancer.

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 Intensity-Modulated Proton Beam Therapy (IMPT) safe for treating oropharyngeal cancer?

Research suggests that IMPT may be safer than traditional radiation therapy (IMRT) for oropharyngeal cancer, as it tends to cause fewer and less severe side effects like pain, dry mouth, difficulty swallowing, and nausea. This is because IMPT can target the cancer more precisely, reducing the radiation dose to healthy tissues. ^{1 2 3 4 5}

How does the treatment of IMPT and IMRT for oropharyngeal cancer differ from other treatments?

IMPT (Intensity-Modulated Proton Therapy) is unique because it can reduce the radiation dose to surrounding healthy organs while still effectively targeting the cancer, potentially leading to fewer side effects compared to IMRT (Intensity-Modulated Radiation Therapy). This is particularly beneficial for patients with HPV-associated oropharyngeal cancer, as it may improve their quality of life by reducing issues like pain and difficulty swallowing. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Intensity-Modulated Proton Beam Therapy (IMPT) and Intensity-Modulated Radiation Therapy (IMRT) for oropharyngeal cancer?

Research suggests that IMPT can reduce side effects like pain and difficulty swallowing compared to traditional radiation therapy, while still effectively targeting the cancer. Studies also show that IMRT can reduce damage to healthy tissues, improving quality of life without compromising cancer control. ^{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 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]

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]

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]

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]

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]

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]

Citations

1. Ireland 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. [2022]

2. Switzerland 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. [2021]

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

Proton Therapy for HPV-Associated Oropharyngeal Cancers of the Head and Neck: a De-Intensification Strategy. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. 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]

6. United States 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. [2023]

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

Dosimetric advantages of intensity-modulated proton therapy for oropharyngeal cancer compared with intensity-modulated radiation: A case-matched control analysis. [2022]