Reduced Radiation Doses for Throat Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMichael Sim, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Indiana University

No Placebo Group

Trial Summary

What is the purpose of this trial?

Oropharyngeal squamous cell carcinoma (OPSCC), commonly known as throat cancer or tonsil cancer, has seen a dramatic rise in incidence over the last twenty years. There are two types of OPSCC: human papillomavirus-positive (HPV+) and human papillomavirus-negative (HPV-). People with OPSCC, regardless of their type, typically receive standard treatment with a combination of chemotherapy, radiation therapy, and surgery. Due to the intensity of standard treatment, survivors may experience unwanted long-term side effects. The goal of this research study is to see if intensifying (stopping or scaling back) treatment still provides the same, or perhaps even better, results when compared to standard treatment.

Research Team

Michael Sim, MD

Principal Investigator

Indiana University School of Medicine, Indiana University Simon Cancer Center

Eligibility Criteria

This trial is for adults over 18 with HPV-positive throat cancer that can be removed surgically. They should have a performance status indicating they are relatively active and must not have distant spread of cancer or other cancers in the last 5 years, except certain skin and thyroid cancers. Women must not be pregnant or breastfeeding.

Inclusion Criteria

My cancer is confirmed as squamous cell carcinoma.

I am 18 years old or older.

I have more than one primary cancer at the same time.

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Exclusion Criteria

I have a health condition that makes general anesthesia unsafe for me.

I have not had head or neck radiation or cancer in the last 3 years.

I am of childbearing age and have a recent negative pregnancy test.

See 5 more

Treatment Details

Interventions

44 doses of radiation (Radiation)
54 doses of radiation (Radiation)

Trial OverviewThe study is testing if reducing the intensity of treatment after surgery for HPV-positive throat cancer by giving fewer radiation doses (44 instead of the standard 54) affects recovery outcomes. It aims to see if less intense treatment leads to similar or better results than current standards.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Adjuvant Radiation 54 GrayExperimental Treatment1 Intervention

If patients have 4 or fewer positive nodes with greater than 2 mm of cancer spread extending outside the lymph nodes or 5 or more positive nodes with 2 mm or less of cancer spread extending outside the lymph nodes, patients will receive 54 gray fractions (the full dose of radiation divided into smaller doses) of adjuvant radiation.

Group II: Adjuvant Radiation 44 GrayExperimental Treatment1 Intervention

If patients have 4 or fewer positive nodes and 2 mm or less of cancer spread extending outside the lymph nodes, patients will receive 44 gray fractions (the full dose of radiation divided into smaller doses) of adjuvant radiation.

Group III: ObservationActive Control1 Intervention

If patients have negative margins and have all negative nodes or only a single positive node, patients will be placed in the observation arm and will not receive further adjuvant treatment, only postoperative follow-up visits and a surveillance visit 3 months after surgery with a CT or PET-CT.