150 Participants Needed

Reduced Radiation Therapy for Oropharyngeal Cancer

JN
Overseen ByJ. Nicholas Lukens, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Abramson Cancer Center at Penn Medicine
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This is a single-arm Phase II study of adjuvant radiation for locally advanced p16+ oropharyngeal squamous cell carcinoma. The main purpose of this research is to determine the likelihood of cancer growing back in the throat or in the neck two years after completion of radiation if lower doses of radiation are used to a smaller area of the head and neck region than is currently used in standard of care.

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 for oropharyngeal cancer?

Research shows that intensity-modulated radiotherapy (IMRT) is effective for treating oropharyngeal cancer, offering benefits like reduced dry mouth and improved quality of life. Combining IMRT with proton therapy may further reduce side effects, making it a promising option for patients.12345

Is reduced radiation therapy for oropharyngeal cancer safe for humans?

Modern radiation therapies like intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT) are generally safe and can reduce side effects compared to older methods. They help protect normal tissues while effectively treating tumors, leading to fewer complications such as dry mouth and better quality of life.46789

How is reduced radiation therapy unique for treating oropharyngeal cancer?

Reduced radiation therapy, particularly using intensity-modulated radiation therapy (IMRT), is unique because it can target the cancer more precisely, sparing more of the healthy tissue around the tumor. This approach reduces side effects like salivary gland damage while maintaining effective tumor control.2381011

Eligibility Criteria

This trial is for adults over 18 with a specific throat cancer (p16+ oropharyngeal squamous cell carcinoma) that hasn't spread too far. They should be in good physical shape and have no more than four affected lymph nodes. People with very advanced disease, distant spread of cancer, previous head/neck radiation, or more than four positive lymph nodes can't join.

Inclusion Criteria

My cancer is at an early or middle stage according to its size and extent.
My throat cancer is confirmed to be p16 positive.
My cancer has spread to fewer than 5 lymph nodes.
See 1 more

Exclusion Criteria

My cancer has spread to distant parts of my body.
My cancer has spread to nearby tissues.
>= 5 lymph nodes
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo Transoral Robotic Surgery (TORS) and neck dissection

4-6 weeks

Radiation

Participants receive de-intensified adjuvant radiation therapy to the primary site and regional lymphatics

6-8 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes after treatment

2.5 years

Treatment Details

Interventions

  • Radiation Therapy
Trial Overview The study tests if using lower doses of radiation to a smaller area in the head and neck region is effective for treating throat cancer without it coming back within two years. It's a Phase II trial where all participants receive this modified radiation therapy.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
All patients will have the volume treated and radiation dose delivered to the regional lymphatics decreased according to the characteristics of the primary site and involved lymph nodes. The high risk neck will receive 50 Gy instead of 60 Gy, and the treated volume of the contralateral low risk neck will be reduced and receive only 45 Gy.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
πŸ‡ΊπŸ‡Έ
Approved in United States as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
πŸ‡¨πŸ‡¦
Approved in Canada as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
πŸ‡―πŸ‡΅
Approved in Japan as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
πŸ‡¨πŸ‡³
Approved in China as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
πŸ‡¨πŸ‡­
Approved in Switzerland as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials
425
Recruited
464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials
360
Recruited
108,000+

Findings from Research

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

References

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]
Changing failure patterns in oropharyngeal squamous cell carcinoma treated with intensity modulated radiotherapy and implications for future research. [2006]
Intensity-modulated radiotherapy for oropharyngeal squamous cell carcinoma. [2022]
Advances in radiation oncology for the management of oropharyngeal tumors. [2018]
Simultaneously Integrated Boost Affects Survival in Locally Advanced p16-Negative Oropharyngeal Squamous Cell Carcinoma. [2022]
Current strategies in radiotherapy of head and neck cancer. [2021]
Oral complications of head and neck radiotherapy: prevalence and management. [2017]
Intensity-modulated radiation therapy reduces late salivary toxicity without compromising tumor control in patients with oropharyngeal carcinoma: a comparison with conventional techniques. [2022]
Intensity-modulated radiotherapy in the treatment of oropharyngeal cancer: clinical outcomes and patterns of failure. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Is there a "mucosa-sparing" benefit of IMRT for head-and-neck cancer? [2006]
11.United Statespubmed.ncbi.nlm.nih.gov
Dosimetric Results for Adjuvant Proton Radiation Therapy of HPV-Associated Oropharynx Cancer. [2022]