Reduced Radiation Doses for Throat Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether lower doses of radiation can effectively treat throat cancer while reducing long-term side effects. Participants will receive either 44 or 54 doses of radiation, depending on the cancer's spread, or may be observed after surgery if they meet certain criteria. This trial suits individuals with surgically removable throat cancer, particularly if linked to HPV, a common virus. The researchers aim to balance effective treatment with minimizing radiation's harsh effects. As an unphased trial, it allows participants to contribute to important research that could enhance future treatment options.
Will I have to stop taking my current medications?
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lower radiation doses can safely treat throat cancer. For those receiving 44 doses of radiation, studies have found typical doses range from 44 to 60 Gy (a measure of radiation), and patients generally tolerate them well. Many patients even receive up to 70 Gy without serious side effects, suggesting that 44 Gy might be easier on the body.
For the 54-dose treatment, research on reduced radiation for HPV-positive throat cancer has shown promising safety results. One study found that lowering the radiation dose can still be effective and improve quality of life by reducing long-term side effects. These findings suggest that the 54-dose treatment is also likely manageable for patients.
Both treatment options aim to be effective while causing fewer side effects, making them potentially safer alternatives to higher-dose treatments.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for throat cancer because they focus on reducing radiation exposure while maintaining effectiveness. Traditionally, patients undergo a standard radiation regimen, which can be taxing and lead to significant side effects. By offering 44 or 54 gray fractions, these treatments aim to tailor radiation doses based on the extent of cancer spread, potentially reducing the risk of side effects. This personalized approach could lead to improved quality of life for patients while effectively managing the cancer.
What evidence suggests that this trial's treatments could be effective for throat cancer?
This trial will compare different radiation doses for throat cancer treatment. Research has shown that lowering the radiation dose can be effective and reduce side effects. Participants may receive 44 doses of radiation. Studies have found that patients, especially those with HPV-positive cancer, can achieve successful results with fewer side effects, leading to a better quality of life. Alternatively, participants may receive 54 doses of radiation. Research indicates that this approach can also significantly reduce side effects for HPV-positive throat cancer while still effectively controlling the cancer. Both options in this trial aim to balance effective treatment with fewer long-term side effects.678910
Who Is on the Research Team?
Michael Sim, MD
Principal Investigator
Indiana University School of Medicine, Indiana University Simon Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with HPV-positive throat cancer that can be removed surgically. They should have a performance status indicating they are relatively active and must not have distant spread of cancer or other cancers in the last 5 years, except certain skin and thyroid cancers. Women must not be pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo transoral robotic surgery (TORS) for HPV+ OPSCC
Adjuvant Treatment
Participants receive adjuvant radiation therapy based on risk stratification
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 44 doses of radiation
- 54 doses of radiation
Trial Overview
The study is testing if reducing the intensity of treatment after surgery for HPV-positive throat cancer by giving fewer radiation doses (44 instead of the standard 54) affects recovery outcomes. It aims to see if less intense treatment leads to similar or better results than current standards.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
If patients have 4 or fewer positive nodes with greater than 2 mm of cancer spread extending outside the lymph nodes or 5 or more positive nodes with 2 mm or less of cancer spread extending outside the lymph nodes, patients will receive 54 gray fractions (the full dose of radiation divided into smaller doses) of adjuvant radiation.
If patients have 4 or fewer positive nodes and 2 mm or less of cancer spread extending outside the lymph nodes, patients will receive 44 gray fractions (the full dose of radiation divided into smaller doses) of adjuvant radiation.
If patients have negative margins and have all negative nodes or only a single positive node, patients will be placed in the observation arm and will not receive further adjuvant treatment, only postoperative follow-up visits and a surveillance visit 3 months after surgery with a CT or PET-CT.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Citations
Outcomes of Reduced Elective Nodal Radiation Dose for ...
Reducing elective nodal irradiation dose can decrease treatment toxicity and improve quality of life for head and neck cancer patients.
Dose Escalation of Oropharyngeal Cancer: Long-Time ...
Previous studies on dose-escalated radiotherapy in head and neck cancer have shown mixed results, and it is not established which patients would benefit from ...
Outcomes of Reduced Elective Nodal Radiation Dose for ...
Reducing elective nodal irradiation dose can decrease treatment toxicity and improve quality of life for head and neck cancer patients.
Phase II Trial of Radiation Dose De-escalation for Human ...
Our findings that patients with HPV-associated oropharyngeal squamous cell carcinoma can successfully be treated with reduced doses of radiation
Elective Radiotherapy Dose and Field in HPV-Associated ...
All 276 patients were prescribed a radiation dose of 30 Gy to the elective and subclinical regions and cone down to 70 Gy to the gross disease.
Radiation Dose Volume Effects in the Larynx and Pharynx
A. Many studies have shown a good voice outcome following RT for T1 laryngeal cancer (typically 60-66 Gy without chemotherapy). In the locally advanced setting ...
Interventions for the treatment of oral cavity and ...
Treatment of oral cavity cancer is generally surgery followed by radiotherapy, whereas oropharyngeal cancers, which are more likely to be advanced at the time ...
Treatment of recurrent head and neck cancer: re-irradiation ...
Persistent or recurrent disease after standard radiation doses of 60–70 Gy for primary tumours and 44–60 Gy for lymph-node-bearing regions may be because of ...
Toxicity Profiles and Survival Outcomes Among Patients ...
Most patients (283 [97%]) received a dose to the primary tumor of 70 Gy. Fifty-seven of the patients treated with IMPT (98%) and 215 of those ...
Radiation Therapy for HPV-Positive Oropharyngeal ...
Cervical nodal level V can safely be omitted in the treatment of locally advanced oropharyngeal squamous cell carcinoma with definitive IMRT.
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