Radiation Therapy for Oropharyngeal Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Disqualifiers: Prior RT, Major surgery, Uncontrolled illness, 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: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to radiation therapy for individuals with HPV-related oropharyngeal cancer. The researchers aim to determine if reducing the radiation dose to specific neck areas can maintain cancer control while minimizing side effects, potentially improving patients' quality of life during treatment. This trial suits those diagnosed with HPV-related oropharyngeal cancer who have not yet begun treatment. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants an opportunity 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 your doctor or the trial team.

What prior data suggests that this method of decreased radiation dose is safe for HPV-related oropharyngeal cancer patients?

Research has shown that lowering the radiation dose to the neck area in patients with HPV-related throat cancer might be safe. Several studies have found that reducing radiation can still effectively treat the cancer and may improve patients' quality of life. One study found that this approach led to high survival rates, with 90.6% of patients experiencing no cancer worsening and 95.3% still alive. This suggests that reducing the radiation dose might help lessen side effects without reducing treatment effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for oropharyngeal cancer, which typically involves a full dose of radiation therapy to both the tumor and the neck lymph nodes, this new approach reduces the radiation dose to the elective neck lymph nodes. Researchers are excited about this technique because it aims to minimize side effects while still effectively targeting the cancer. By decreasing the radiation exposure to healthy tissues in the neck, patients may experience fewer treatment-related complications, potentially leading to an improved quality of life during and after therapy.

What evidence suggests that decreasing the dose of radiation therapy to the elective neck is effective for HPV-related oropharyngeal cancer?

This trial will evaluate the effects of lowering the radiation dose to certain neck lymph nodes in patients with oropharyngeal cancer. Studies have shown that this approach can reduce treatment side effects and improve patients' quality of life without compromising treatment effectiveness. Previous research indicated that patients did not experience more cancer recurrence in the lymph nodes when the radiation dose was reduced. This suggests that lowering the radiation dose is both safe and effective for treating HPV-related oropharyngeal cancer. Overall, the results remain positive while reducing the harmful effects of radiation. ^{2 6 7 8 9}

Who Is on the Research Team?

Laila A Gharzai

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for patients with HPV-related oropharyngeal cancer. It's focused on those who might benefit from reduced radiation to the neck lymph nodes not directly affected by cancer, aiming to maintain treatment effectiveness while lessening side effects.

Inclusion Criteria

My throat cancer is confirmed to be HPV-related.

I have not had any previous cancer treatment.

I am 18 years old or older.

Exclusion Criteria

I do not have any health conditions that would stop me from safely receiving radiation therapy.

My cancer is classified as advanced according to AJCC 8th edition.

I have had radiation therapy to my head/neck that cannot be repeated in the same area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard dose radiation therapy to the tumor and reduced dose radiation therapy to the elective neck lymph nodes five days per week for a total of 35 fractions over 7 weeks. Patients also undergo CT, PET, and nasopharyngolaryngoscopy throughout the trial.

7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 3 months for 2 years.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Decreased Dose of Radiation Therapy to the Elective Neck

Trial Overview The ENLIGHT Trial is testing whether lowering radiation doses in elective neck areas during therapy can still effectively treat HPV-related oropharyngeal cancer while reducing harmful side effects and improving quality of life.

How Is the Trial Designed?

Group I: Treatment (radiation therapy) Experimental Treatment 5 Interventions

Patients receive standard dose radiation therapy to the tumor and reduced dose radiation therapy to the elective neck lymph nodes five days per week for a total of 35 fractions over 7 weeks. Patients also undergo CT, PET, and nasopharyngolaryngoscopy throughout the trial.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. redjournal.org redjournal.org/article/S0360-3016(24)02534-3/fulltext

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.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40515499/

Outcomes of Reduced Elective Nodal Radiation Dose and ... Conclusions: Reduction in elective nodal radiation dose did not lead to solitary elective nodal recurrences for laryngeal, hypopharyngeal, and ...

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2788326

Elective Radiotherapy Dose and Field in HPV-Associated ... This cohort study found that the evaluated de-escalation strategy for elective regions showed favorable clinical outcomes and QOL profiles.

4. ascopubs.org ascopubs.org/doi/pdf/10.1200/JCO-24-02194

Clinical Benefit and Safety of Reduced Elective Dose in CONCLUSION This is the second randomized controlled trial demonstrating that reduced elective dose is safe in definitive RT for HNC.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025052004

Dose de-escalation of elective neck irradiation in head and ... Reduced elective dose resulted in significantly more patients with a pharyngeal mucosal epithelium mean dose below 45 Gy. This was associated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8078254/

Reduced-Dose Radiation Therapy for HPV-Associated ... Reducing radiation treatment dose could improve the quality of life (QOL) of patients with good-risk human papillomavirus–associated oropharyngeal squamous ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07178301

Evaluating a Decreased Dose of Radiation Therapy to the ... Reducing the dose of radiation therapy to the lymph nodes in the neck that aren't directly involved in the cancer may improve patient quality ...

8. medicine.yale.edu medicine.yale.edu/news-article/reducing-radiation-after-surgery-prolongs-survival-for-some-patients-with-hpv-related-throat-cancer/

Reducing Radiation After Surgery Prolongs Survival for Some ... “Long-term follow up now demonstrates remarkable progression-free and overall survivals of 90.6% and 95.3% for the overall group,” said the ...

9. ecog-acrin.org ecog-acrin.org/press-release-new-post-surgery-treament-for-hpv-throat-cancer-uses-less-radiation-safely-and-eliminates-chemotherapy/

A new post-surgery approach for treating HPV-related ... Trial E3311 shows the benefits and safety of transoral surgery (TOS) and low-dose radiation in patients at medium risk.