Radiation Therapy for Throat Cancer

(RAD RAPTORS Trial)

Overseen By Shane Lloyd

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Must not be taking: Anti-cancer, Investigational drugs

Disqualifiers: Prior head/neck cancer, Metastatic disease, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 10 fractions

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a shorter course of radiation therapy can improve life quality for throat cancer patients after surgery. The study compares two groups: one receiving a brief round of radiation and the other following standard care, which may include chemotherapy. It targets individuals with throat cancer who have undergone robotic surgery and tested positive for HPV, a virus linked to cancer. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer care.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to understand how your medications might interact with the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that a shorter course of radiation therapy can be safer and easier for patients with throat cancer. Research indicates that this less intense approach significantly reduces severe side effects, which are more common with longer treatments. Patients report fewer moderate to severe reactions, experiencing fewer problems during and after therapy.

While researchers continue testing the treatment, this phase usually involves gathering safety data. However, existing evidence suggests it is generally well-tolerated. The reduced side effects can lead to a better quality of life for those receiving this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatment for throat cancer, which often involves several weeks of radiation therapy, this new approach uses a shortened course consisting of just 10 fractions of radiation therapy. Researchers are excited because this could significantly reduce the overall treatment time while maintaining effectiveness, making it more convenient for patients. Shortening treatment duration without compromising outcomes could also lessen the side effects associated with prolonged radiation exposure, improving patients' quality of life.

What evidence suggests that this shortened course of radiation therapy might be an effective treatment for throat cancer?

Research has shown that a shorter course of radiation therapy, which participants in this trial may receive, can effectively treat certain throat cancers. Studies have found that reducing the radiation dose can lessen severe side effects. This approach can also enhance patients' quality of life. For those with HPV-related throat cancers, the less intense treatment has decreased treatment-related problems. Overall, shorter radiotherapy is considered safe and effective for some head and neck cancers, providing results similar to traditional, longer treatments. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with HPV-related oropharyngeal squamous cell carcinoma who have undergone trans-oral robotic surgery. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to follow specific guidelines during the trial.

Inclusion Criteria

I am 18 years old or older.

Pre- and post-operative TTMV-HPV DNA test results obtained

Pre-operative TTMV-HPV DNA test collected

Exclusion Criteria

Participant has smoked cigarettes within 1 month of registration

Current evidence of any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures

Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a shortened course of radiation therapy after trans-oral robotic surgery

10 fractions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Shortened Course of Radiation Therapy

Trial Overview The study is testing whether a shorter course of radiation therapy after surgery can enhance quality of life for throat cancer patients compared to traditional longer courses.

How Is the Trial Designed?

Group I: 10 fractions of radiation therapy Experimental Treatment 1 Intervention

Group II: Radiation therapy with chemotherapy, if applicable, per standard of care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. newsnetwork.mayoclinic.org newsnetwork.mayoclinic.org/discussion/shorter-less-intense-radiation-chemo-regimen-effective-for-hpv-linked-oropharyngeal-cancer-mayo-study-shows/

Shorter, less intense radiation-chemo regimen effective for ... The results demonstrated that the less intensive treatment approach significantly reduced both severe (grade 3 or higher) and moderate (grade 2) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9843369/

Reduced-dose radiation in human papillomavirus ... Reducing the radiation dose in patients with HPV-related OPC substantially alleviates the treatment toxicities and optimizes the quality of life of patients.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0167814022002523

Characterization of clinical outcomes after shorter course ... Characterization of clinical outcomes after shorter course hypofractionated and standard-course radiotherapy for stage I-III curatively-treated Merkel cell ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04178174

Stereotactic Boost and Short-course Radiation Therapy for ... The goal of this trial is to compare the efficacy and safety of short-course chemoradiation consisting in stereotactic boost to the gross tumor of 14 Gy in 2 ...

5. oncologynewscentral.com oncologynewscentral.com/article/shorter-radiotherapy-safe-effective-in-some-head-and-neck-cancers

Shorter Radiotherapy Safe, Effective in Some Head and ... Radiation treatment may be safely shortened for some patients with locally advanced head and neck cancer while providing similar efficacy.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07044635

Shortened Course of Radiation Therapy After Trans-oral ... The goal of this study is to evaluate if a shorter course of therapy can improve the quality of life in patients receiving radiation therapy after ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12316137/

Clinical Benefit and Safety of Reduced Elective Dose in ... Definitive radiotherapy (RT) for head and neck cancer (HNC) has significant long-term toxicity with elective neck irradiation (ENI) as a major ...

8. practicalradonc.org practicalradonc.org/article/S1879-8500(24)00139-5/fulltext

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.