Reduced Radiation Therapy for Oropharyngeal Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abramson Cancer Center at Penn Medicine

Stay on Your Current Meds

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a single-arm Phase II study of adjuvant radiation for locally advanced p16+ oropharyngeal squamous cell carcinoma. The main purpose of this research is to determine the likelihood of cancer growing back in the throat or in the neck two years after completion of radiation if lower doses of radiation are used to a smaller area of the head and neck region than is currently used in standard of care.

Eligibility Criteria

This trial is for adults over 18 with a specific throat cancer (p16+ oropharyngeal squamous cell carcinoma) that hasn't spread too far. They should be in good physical shape and have no more than four affected lymph nodes. People with very advanced disease, distant spread of cancer, previous head/neck radiation, or more than four positive lymph nodes can't join.

Inclusion Criteria

My cancer is at an early or middle stage according to its size and extent.

My throat cancer is confirmed to be p16 positive.

My cancer has spread to fewer than 5 lymph nodes.

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Exclusion Criteria

My cancer has spread to distant parts of my body.

My cancer has spread to nearby tissues.

>= 5 lymph nodes

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Treatment Details

Interventions

Radiation Therapy (Radiation Therapy)

Trial OverviewThe study tests if using lower doses of radiation to a smaller area in the head and neck region is effective for treating throat cancer without it coming back within two years. It's a Phase II trial where all participants receive this modified radiation therapy.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

All patients will have the volume treated and radiation dose delivered to the regional lymphatics decreased according to the characteristics of the primary site and involved lymph nodes. The high risk neck will receive 50 Gy instead of 60 Gy, and the treated volume of the contralateral low risk neck will be reduced and receive only 45 Gy.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Radiation Therapy for: