440 Participants Needed

Radiation Therapy for Oropharyngeal Cancer

Recruiting at 30 trial locations
SJ
Overseen BySteven J. Frank, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: M.D. Anderson Cancer Center
Must be taking: Chemotherapy
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

Trial Summary

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.

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.12345

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.12367

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.12356

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.

Research Team

SJ

Steven J. Frank

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.
See 3 more

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm II (IMPT)Experimental Treatment4 Interventions
Patients undergo IMPT QD five days a week for approximately 6.5 weeks.
Group II: Arm I (IMRT)Experimental Treatment4 Interventions
Patients undergo IMRT QD five days a week for approximately 6.5 weeks.

Find a Clinic Near You

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+

Findings from Research

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.
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.
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.
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]

References

Intensity-modulated proton beam therapy (IMPT) versus intensity-modulated photon therapy (IMRT) for patients with oropharynx cancer - A case matched analysis. [2022]
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]
Proton Therapy for HPV-Associated Oropharyngeal Cancers of the Head and Neck: a De-Intensification Strategy. [2022]
Quality of Life and Patient-Reported Outcomes Following Proton Therapy for Oropharyngeal Carcinoma: A Systematic Review. [2023]
Intensity-modulated radiation therapy reduces late salivary toxicity without compromising tumor control in patients with oropharyngeal carcinoma: a comparison with conventional techniques. [2022]
Toxicity Profiles and Survival Outcomes Among Patients With Nonmetastatic Oropharyngeal Carcinoma Treated With Intensity-Modulated Proton Therapy vs Intensity-Modulated Radiation Therapy. [2023]
Dosimetric advantages of intensity-modulated proton therapy for oropharyngeal cancer compared with intensity-modulated radiation: A case-matched control analysis. [2022]
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