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Radiation

Reduced Radiation Doses for Throat Cancer

N/A

Waitlist Available

Led By Michael Sim, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histopathologically confirmed squamous cell carcinoma

Subjects ≥ 18 years old at the time of informed consent

Must not have

Serious medical condition preventing general anesthesia for surgery

History of previous head and neck radiation or previous head and neck cancer within 3 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 months, 6 months, 1 year, and 2 year post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if less intense treatment for throat cancer is as effective as the current standard of care.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects from reduced radiation may include skin irritation, fatigue, dry mouth, difficulty swallowing, changes in taste, dental problems, and possibly a lower risk of long-term complications compared to standard treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed as squamous cell carcinoma.

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I am 18 years old or older.

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My cancer is in an early stage (T1 or T2).

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My cancer has spread to nearby lymph nodes but not to distant parts of my body.

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My tumor is HPV positive.

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My neck nodes can be felt and moved upon examination.

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I can take care of myself and am up and about more than half of the day.

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My tumor can likely be completely removed by surgery.

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My cancer originates in the back of my throat.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I cannot complete all radiation treatments or attend follow-up visits.

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 months, 6 months, 1 year, and 2 year post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 months, 6 months, 1 year, and 2 year post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months, 6 months, 1 year, and 2 year post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease free survival

Secondary study objectives

Distant metastasis rates

Gastrostomy tube dependence rates

Loco-regional control

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 13Eligibility criteria met