30 Participants Needed

Radiation for Throat Cancer

(Lombardi197 Trial)

Recruiting at 1 trial location
NS
PH
Overseen ByPeter H Ahn, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.1112131415

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

PA

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
See 6 more

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.
See 3 more

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
1Treatment groups
Experimental Treatment
Group I: Radiation onlyExperimental Treatment1 Intervention
Radiation therapy only to a dose of 66Gy to gross disease

Find a Clinic Near You

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.
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.
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.
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]

References

Role of neck surgery in conjunction with radiation in regional control of node-positive cancer of the oropharynx. [2019]
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]
Cervical lymph node metastases--diagnostic, therapeutic, and prognostic implications. [2005]
Retrospective analysis of self-reporting pain scores and pain management during head and neck IMRT radiotherapy: A single institution experience. [2022]
Effective Biomarkers and Radiation Treatment in Head and Neck Cancer. [2022]
Managing side effects of radiotherapy in head and neck cancer. [2019]
Monitoring Adverse Effects of Radiation Therapy in Patients With Head and Neck Cancer: The FACT-HN-RAD Patient-Reported Outcome Measure. [2023]
Management of Radiation Toxicity in Head and Neck Cancers. [2018]
Appetite and adverse effects associated with radiation therapy in patients with head and neck cancer. [2022]
The clinician's guide to radiotherapy complications. [2022]
[Current status of radiation therapy--evidence-based medicine (EBM) of radiation therapy. Radiotherapy for pharyngeal and laryngeal cancer]. [2011]
[Cobalt teletherapy of patients with pharyngeal cancer]. [2015]
Radiation of jejunal interposition in T3-T4 upper aerodigestive tumours. [2019]
Case series report: radiation-induced oropharyngeal carcinoma. [2023]
[Carcinomas of the posterior pharyngeal wall. Experience of the Institut Curie. Analysis of the results of radiotherapy]. [2006]
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