Reduced-Dose Radiation Therapy for Oropharyngeal Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Emory University
No Placebo Group
Prior Safety Data
Approved in 6 jurisdictions
Trial Summary
What is the purpose of this trial?This phase II trial tests whether reduced dose radiation therapy after transoral robotic surgery works in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer. HPV positive oropharyngeal cancer has a better prognosis than oropharyngeal cancer not caused by HPV. A standard of care treatment for HPV positive oropharyngeal cancer is transoral robotic surgery followed by radiation therapy. However, this treatment is associated with many long-term side effects including difficulty swallowing. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving reduced dose radiation therapy after transoral robotic surgery may improve swallowing outcomes and quality of life compared to standard of care dose radiation therapy after transoral robotic surgery.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on investigational drugs or have had recent chemotherapy or radiotherapy, you may not be eligible to participate.
What data supports the effectiveness of this treatment for oropharyngeal cancer?
Research shows that intensity-modulated radiotherapy (IMRT) is effective for treating oropharyngeal cancer, with benefits like reduced dry mouth and improved quality of life. Combining IMRT with proton therapy may further reduce side effects while maintaining effective tumor treatment.
12345Is reduced-dose radiation therapy for oropharyngeal cancer safe for humans?
Modern radiation therapies like intensity-modulated radiation therapy (IMRT) and intensity-modulated proton therapy (IMPT) are generally safe and can reduce side effects like dry mouth and damage to surrounding tissues compared to older methods. However, patients may still experience some toxic effects, so it's important to discuss potential risks with your doctor.
13678How is reduced-dose radiation therapy unique for treating oropharyngeal cancer?
Reduced-dose radiation therapy, particularly using intensity-modulated radiation therapy (IMRT), is unique because it can spare more normal tissue, like the mucosa (lining of the mouth and throat), and reduce side effects such as salivary gland damage, while still effectively controlling the tumor.
23569Eligibility Criteria
Adults with HPV-positive oropharyngeal cancer who've had surgery and limited smoking history can join this trial. They must have a life expectancy over 12 weeks, be in good enough health to perform daily activities, and agree to use contraception. Those with extensive cancer spread, recent other cancers, or severe illnesses are excluded.Inclusion Criteria
My cancer has one of the following: close margin, perineural invasion, lymphovascular invasion, 2-4 positive lymph nodes without ENE, or a single lymph node larger than 3 cm without ENE.
I have been diagnosed with a type of throat cancer linked to HPV.
I have smoked 10 or fewer packs of cigarettes a year.
I am 18 years old or older.
I can take care of myself but might not be able to do active work.
My cancer is HPV positive.
My cancer is in early stages and hasn't spread far.
I had robotic surgery for throat cancer and neck dissection at Emory.
Exclusion Criteria
I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
I have not had cancer, except for non-dangerous skin cancer, in the last 2 years.
I haven't had major heart or blood vessel problems in the last 3 months.
I haven't had chemotherapy or radiotherapy in the last 4 weeks and have no lasting side effects.
Participant Groups
The trial is testing if lower doses of radiation therapy after robotic surgery improve swallowing and quality of life for patients with HPV-positive throat cancer compared to the standard higher doses usually given after such surgeries.
1Treatment groups
Experimental Treatment
Group I: Treatment (reduced dose radiation therapy)Experimental Treatment1 Intervention
Patients who are ctHPVDNA negative after surgery undergo reduced dose radiation therapy for 3 weeks (15 treatments). Patients who are ctHPVDNA positive after surgery undergo standard of care radiation therapy.
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇺🇸 Approved in United States as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇦 Approved in Canada as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇯🇵 Approved in Japan as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇳 Approved in China as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇭 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
Research locations nearbySelect from list below to view details:
Emory University Hospital/Winship Cancer InstituteAtlanta, GA
Emory University Midtown HospitalAtlanta, GA
Vanderbilt University Medical CenterNashville, TN
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Who is running the clinical trial?
Emory UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Advances in radiation oncology for the management of oropharyngeal tumors. [2018]The major benefits of modern radiation therapy (eg, intensity-modulated [x-ray] radiation therapy [IMRT]) for oropharyngeal cancer are reduced xerostomia and better quality of life. Intensity-modulated proton therapy may provide additional advantages over IMRT by reducing radiation beam-path toxicities. Several acute and late treatment-related toxicities and symptom constellations must be kept in mind when designing and comparing future treatment strategies, particularly because currently most patients with oropharyngeal carcinoma present with human papillomavirus-positive disease and are expected to have a high probability of long-term survival after treatment.
Intensity-modulated radiotherapy for oropharyngeal squamous cell carcinoma. [2022]To report the outcomes after intensity-modulated radiotherapy (IMRT) for patients with oropharyngeal squamous cell carcinoma.
Changing failure patterns in oropharyngeal squamous cell carcinoma treated with intensity modulated radiotherapy and implications for future research. [2006]Review the University of Iowa experience with intensity modulated radiation treatment (IMRT) in oropharyngeal squamous cell carcinoma.
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]To report the early clinical outcomes of combining intensity-modulated radiation therapy (IMRT) and intensity-modulated proton therapy (IMPT) in comparison with IMRT alone in treating oropharynx cancer (OPC) patients.
Intensity-modulated proton beam therapy (IMPT) versus intensity-modulated photon therapy (IMRT) for patients with oropharynx cancer - A case matched analysis. [2022]Owing to its physical properties, intensity-modulated proton therapy (IMPT) used for patients with oropharyngeal carcinoma has the ability to reduce the dose to organs at risk compared to intensity-modulated radiotherapy (IMRT) while maintaining adequate tumor coverage. Our aim was to compare the clinical outcomes of these two treatment modalities.
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 radiation therapy (IMRT) offers superior dosimetric conformity for normal tissue sparing in patients with oropharyngeal cancer. In this study, acute and late toxicity, and tumor control were compared between conventional beam arrangement (CRT) and IMRT.
Current strategies in radiotherapy of head and neck cancer. [2021]The Intensity Modulated Radiation Therapy (IMRT) together with Image Guided Radiation Therapy (IGRT) improves radiation therapy for head and neck cancer. On the one hand tumors can be better covered with radiation dose and on the other hand normal tissue can be better preserved. Carefully applied this leads to the same tumor control rate with reduced toxicity compared with conventional radiation therapy. Respective to the addition of systemic therapy to irradiation therapy, platinum based radiochemotherapy remains the standard of care and there are first indications, that at least in the primary treatment of head and neck cancer the addition of Cetuximab to a cisplatin-based radiochemotherapy did not improve outcome.
Toxicity Profiles and Survival Outcomes Among Patients With Nonmetastatic Oropharyngeal Carcinoma Treated With Intensity-Modulated Proton Therapy vs Intensity-Modulated Radiation Therapy. [2023]Patients with oropharyngeal carcinoma (OPC) treated with radiotherapy often experience substantial toxic effects, even with modern techniques such as intensity-modulated radiation therapy (IMRT). Intensity-modulated proton therapy (IMPT) has a potential advantage over IMRT due to reduced dose to the surrounding organs at risk; however, data are scarce given the limited availability and use of IMPT.
Is there a "mucosa-sparing" benefit of IMRT for head-and-neck cancer? [2006]To investigate whether intensity-modulated radiation therapy (IMRT) allows more mucosal sparing than standard three-field technique (3FT) radiotherapy for early oropharyngeal cancer.