Radiation for Throat Cancer

(Lombardi197 Trial)

Recruiting at 2 trial locations

Overseen By Peter H Ahn, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Level 4 lymph node, Endophytic T3, Large lymph node, Recent malignancy, Pregnant or nursing

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating a type of throat cancer linked to HPV, focusing on whether using only radiation, instead of the usual combination of radiation and chemotherapy, remains effective. The goal is to determine if this method reduces the long-term side effects typically caused by chemotherapy and higher doses of radiation. Individuals diagnosed with HPV-positive or p16-positive throat cancer, who are non-smokers and have a specific cancer stage, might be suitable candidates for this trial. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to less invasive 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.

What prior data suggests that this radiation treatment is safe for throat cancer?

Radiation therapy is an important treatment for throat cancer caused by HPV, and research has shown it works well for these patients. The American Society for Radiation Oncology (ASTRO) recommends it.

However, radiation can cause side effects. Some studies mention the risk of developing new cancers years later, and side effects can vary depending on the treatment area.

This trial aims to reduce these side effects by lowering the radiation dose and omitting chemotherapy. The goal is to maintain treatment effectiveness while easing the burden on the body over time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this radiation treatment for throat cancer because it specifically targets the gross disease with a precise dose of 66Gy, which may lead to more effective results. Unlike standard treatments that can include a combination of surgery, chemotherapy, and radiation, this approach focuses solely on radiation, which might minimize the risks and side effects associated with combining multiple therapies. By honing in on the cancerous area with such accuracy, there's potential for improved outcomes and reduced damage to surrounding healthy tissues.

What evidence suggests that radiation alone might be an effective treatment for throat cancer?

Research has shown that using only radiation, the treatment under study in this trial, can effectively treat early-stage throat cancer, with 75.2% of patients remaining cancer-free after four years. Studies have also examined the timing of radiation treatments and found that it affects outcomes for head and neck cancers. While combining radiation with chemotherapy often succeeds, using just radiation might reduce long-term side effects with minimal loss of effectiveness. However, there is a risk of developing new cancers, particularly in the lungs. Overall, radiation therapy presents a promising option for treating HPV-positive throat cancer. ^{2 3 4 6 7}

Who Is on the Research Team?

Peter Ahn, MD

Principal Investigator

Georgetown University

Are You a Good Fit for This Trial?

This trial is for individuals with HPV or p16-positive oropharyngeal cancer, which includes cancers of the throat, tongue, and tonsils. Participants should have a favorable prognosis and be candidates for definitive radiotherapy without prior treatment.

Inclusion Criteria

My throat cancer is at an early stage and needs combined chemotherapy and radiation.

Subjects must agree to biopsy of areas that are FDG-avid on PET-CT scan 3-4 months after treatment

Patients must have had a neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration

Exclusion Criteria

Patients must not be pregnant or nursing

My kidney cancer is growing inward and is at stage T3.

My cancer has spread to the level 4 lymph nodes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive radiation therapy only to a dose of 66Gy to gross disease

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including local, regional, and distant metastasis control

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Radiation

Trial Overview The study tests if using only radiation therapy at a reduced dose can effectively treat the cancer while minimizing long-term side effects compared to the standard treatment that combines full-dose radiation with chemotherapy.

How Is the Trial Designed?

Group I: Radiation only Experimental Treatment 1 Intervention

Radiation therapy only to a dose of 66Gy to gross disease

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Published Research Related to This Trial

External beam radiation therapy is a common and effective treatment for head and neck cancers, which account for about 3% of all cancers in the U.S., with 62,000 new cases diagnosed each year.

Due to the complex anatomy of the head and neck region, careful planning of radiation therapy is crucial to minimize side effects on critical structures, and the review provides guidelines for managing these side effects and improving patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Radiation Toxicity in Head and Neck Cancers. Siddiqui, F., Movsas, B.[2018]

In a study of 30 patients undergoing radiotherapy for head and neck carcinomas, self-reported pain scores significantly increased from 35 in the first week to 151 by the final week, indicating that pain management is crucial as treatment progresses.

The rise in pain scores, particularly noted in week 3, suggests that radiation-induced inflammation and chemotherapy side effects contribute to increased discomfort, highlighting the need for individualized pain relief strategies and regular treatment reviews to maintain patient comfort and compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of self-reporting pain scores and pain management during head and neck IMRT radiotherapy: A single institution experience. O'Connor, P., Bisson, J., Asplin, P., et al.[2022]

Curative radiotherapy for head and neck cancer leads to significant side effects that can greatly affect patients' quality of life and potentially impact the success of their treatment.

Effective management of these adverse effects is crucial to improve patient outcomes and enhance their overall treatment experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing side effects of radiotherapy in head and neck cancer. Mendes, RL., Nutting, CM., Harrington, KJ.[2019]

The study developed the Functional Assessment of Cancer Therapy-Head and Neck Radiotherapy (FACT-HN-RAD) measure, an 8-item tool that effectively captures the most common adverse effects (AEs) of radiation therapy in patients with head and neck squamous cell carcinoma, based on input from 19 patients and 9 radiation oncologists.

Common AEs identified include difficulty swallowing, oral pain, dry mouth, and weight loss, with the measure demonstrating strong face validity among patients, indicating it accurately reflects their experiences during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring Adverse Effects of Radiation Therapy in Patients With Head and Neck Cancer: The FACT-HN-RAD Patient-Reported Outcome Measure. Gharzai, LA., Mierzwa, ML., Peipert, JD., et al.[2023]

Citations

1. ecancer.org ecancer.org/en/journal/article/1901-outcomes-of-early-stage-oropharyngeal-squamous-cell-carcinoma-patients-treated-with-radical-radiation-a-single-institution-experience

Outcomes of early-stage oropharyngeal squamous cell ... The locoregional relapse-free survival at 4 years was 75.2%. Five patients developed a second malignancy and the lung was the most common site.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5147736/

The impact of radiation treatment time on survival in patients ... We utilize the National Cancer Database to identify the impact of RTT on outcomes in patients with head and neck cancer treated in the era of chemoradiation.

3. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2024/astro24yom

Existing standard chemoradiation superior to ... “In cancer treatment, 98% progression-free survival at two years is a number you just don't see,” said Sue S. Yom, MD, PhD, FASTRO, principal ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2798320

Toxicity Profiles and Survival Outcomes Among Patients ... This cohort study compares the toxic effects and oncologic outcomes associated with intensity-modulated radiation therapy (IMRT) vs ...

5. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/analysis-clarifies-risk-of-second-malignancies-with-radiation-therapy-for-hpv-positive-head-and-neck-cancers

Second Malignancy Risk with RT for HPV+ Head & Neck ... Analysis Clarifies Risk of Second Malignancies with Radiation Therapy for HPV-Positive Head and Neck Cancers. Risk is not trivial; finding ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11223870/

Increasing radiation therapy and lower survival for human ... Studies have shown lower overall survival for patients with head and neck cancer treated at low-volume or community cancer centers.

7. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2024/astro-issues-clinical-guideline-on-radiation-therapy-for-patients-with-hpv-related-throat-cancer

ASTRO issues clinical guideline on radiation therapy ... "Radiation therapy plays a critical role in the treatment of HPV-positive oropharyngeal cancer, offering a highly effective option for patients ...