Reduced Intensity Radiation for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Disqualifiers: Previous head/neck cancer, surgery, pregnancy, 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: 33

74 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if reducing or eliminating radiation treatment to one or both sides of the neck where there is no evidence of cancer can help spare the side effects of radiation treatment for head and neck cancer. In this study, the investigators plan to reduce the amount of radiation treatment received to healthy tissue

Research Team

Wade Thorstad, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults over 18 with certain types of head and neck cancer, specifically in the oral cavity, oropharynx, larynx, or hypopharynx. They should have had surgery already and show no signs of cancer on one or both sides of their neck. The trial isn't open to those who've had previous head and neck cancers (except non-melanoma skin cancer), prior head and neck surgeries, or women who are pregnant or nursing.

Inclusion Criteria

My cancer in the mouth or throat was surgically removed and did not spread to my neck.

I need radiation therapy due to certain high-risk features of my cancer.

I am 18 years old or older.

Exclusion Criteria

I have had surgery on my head or neck before.

I have had head and neck cancer before, but not skin cancer.

I am not pregnant or nursing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive intensity modulated radiation therapy (IMRT) with guidelines for volume contoured based on tumor site and stage

6-7 weeks

33 visits (in-person) for radiation fractions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including imaging studies to assess recurrence

Minimum of 5 years

Quality of Life Assessment

Quality of Life (QOL) is evaluated using the Swallowing and Dryness Questionnaire

22 months

Treatment Details

Interventions

• Intensity modulated radiation therapy

Trial Overview The study is testing whether reducing radiation therapy to areas without evident cancer can lessen side effects for patients with head and neck cancer. It involves adjusting the amount of radiation away from healthy tissue after surgical removal of tumors.

Participant Groups

Group I: Intensity modulated radiation therapy (IMRT) Experimental Treatment 1 Intervention

-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+