Radiation for Throat Cancer

(Lombardi197 Trial)

Recruiting at 1 trial location

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

Trial Summary

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 data supports the effectiveness of the treatment Radiation for Throat Cancer?

Radiation is a key part of treating head and neck cancers, including throat cancer, and has been shown to improve control of the disease and reduce side effects when combined with surgery. Advances in radiation techniques have made it more effective and less harmful, helping to preserve important functions and improve patient outcomes. ^{1 2 3 4 5}

Is radiation therapy generally safe for humans?

Radiation therapy has been used for over 100 years and is effective in treating cancers, but it can cause significant side effects that affect quality of life. These side effects can impact various body systems, including the nervous, respiratory, and cardiovascular systems, and require careful management to minimize risks. ^{6 7 8 9 10}

How does radiation treatment for throat cancer differ from other treatments?

Radiation treatment for throat cancer is unique because it is often the first choice for early-stage cancers and can be combined with other therapies like chemotherapy for advanced cases to improve outcomes. It uses high-energy rays to target and kill cancer cells, and its effectiveness can vary based on the cancer's stage and location. ^{11 12 13 14 15}

What is the purpose of this trial?

The current standard treatment option for Human Papillomavirus (HPV) or p16-positive oropharyngeal cancer is full-dose radiation combined with chemotherapy. Results with chemotherapy combined with full-dose radiation therapy leads to high rates of cure; this has called into question whether therapy can be decreased in intensity since both chemotherapy and radiation have long-term side effects. One approach to decrease intensity of treatment is to give radiation alone (excluding chemotherapy) and to decrease radiation therapy dose. The investigator believes that omitting chemotherapy and decreasing radiation dose both to tumor and the regions of the head and neck at highest risk of potential spread, may have no significant impact on the cancer recurring while potentially leading to fewer long-term side effects.

Research Team

Peter Ahn, MD

Principal Investigator

Georgetown University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Role of neck surgery in conjunction with radiation in regional control of node-positive cancer of the oropharynx. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Consensus Quality Measures and Dose Constraints for Head and Neck Cancer with an emphasis on Oropharyngeal and Laryngeal Cancer from the Veterans Affairs Radiation Oncology Quality Surveillance Program and American Society for Radiation Oncology Expert Panel. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Cervical lymph node metastases--diagnostic, therapeutic, and prognostic implications. [2005]

4. Netherlands 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effective Biomarkers and Radiation Treatment in Head and Neck Cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Managing side effects of radiotherapy in head and neck cancer. [2019]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Management of Radiation Toxicity in Head and Neck Cancers. [2018]

9. Scotland pubmed.ncbi.nlm.nih.gov

Appetite and adverse effects associated with radiation therapy in patients with head and neck cancer. [2022]

10. Poland pubmed.ncbi.nlm.nih.gov

The clinician's guide to radiotherapy complications. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Current status of radiation therapy--evidence-based medicine (EBM) of radiation therapy. Radiotherapy for pharyngeal and laryngeal cancer]. [2011]

12. Poland pubmed.ncbi.nlm.nih.gov

[Cobalt teletherapy of patients with pharyngeal cancer]. [2015]

13. England pubmed.ncbi.nlm.nih.gov

Radiation of jejunal interposition in T3-T4 upper aerodigestive tumours. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Case series report: radiation-induced oropharyngeal carcinoma. [2023]

15. France pubmed.ncbi.nlm.nih.gov

[Carcinomas of the posterior pharyngeal wall. Experience of the Institut Curie. Analysis of the results of radiotherapy]. [2006]