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Radiation

Lymphoscintigraphy for Oropharyngeal Cancer

Phase 2

Recruiting

Led By David Rosenthal, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

cT1-2N0-1 per AJCC 8th edition staging

Age >18 years

Must not have

Prior history of regionally advanced or distant spread cancers

Distant metastatic spread at the time of inclusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new radiation treatment design to reduce side effects of oropharyngeal cancer. It aims to reduce radiation exposure and cut down on the amount of side effects.

Who is the study for?

This trial is for adults over 18 with newly diagnosed HPV+ or p16+ oropharyngeal cancer that hasn't spread across the midline of the neck or to distant parts. Participants must be in good physical condition, able to understand and sign consent, and have no history of head/neck cancer (except minor skin cancers), previous radiation in that area, major surgeries like thyroidectomy, active pregnancy without contraception, iodine allergy, or certain autoimmune diseases.

What is being tested?

The study tests a new radiation treatment targeting only one side of the neck instead of both sides for people with one-sided oropharyngeal cancer. The goal is to see if this approach can effectively treat cancer while reducing side effects and overall radiation exposure compared to traditional methods.

What are the potential side effects?

Potential side effects may include typical reactions from targeted radiation therapy such as skin irritation at the site of treatment, dry mouth, difficulty swallowing due to inflammation inside the throat area, fatigue from body's response to radiation and possible mild allergic reaction related to lymphoscintigraphy procedure.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is in an early stage, not widely spread.

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I am older than 18 years.

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My scans show no cancer spread to the opposite side of my neck or behind my throat.

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I can undergo a lymph node mapping procedure.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I have a new diagnosis of a specific throat cancer linked to HPV.

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My tumor is located on one side and is at least 1cm away from the center of my body.

Exclusion Criteria

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

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I have had cancer that spread beyond its original location.

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My cancer has spread to distant parts of my body.

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I have had surgery to remove my thyroid or lymph nodes in my neck.

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My cancer did not start in the base of my tongue or in my tonsils.

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I am not pregnant and use contraception if I can have children.

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I have not had chemotherapy or surgery for my current tumor.

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I have a recurring or new cancer in my head or neck.

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I have had head or neck cancer before, but not small skin cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1- IpsilateralExperimental Treatment1 Intervention

Participants with ipsilateral-only drainage (Arm 1- Ipsilateral) will be randomized to assign definitive ipsilateral RT (without concurrent chemotherapy) -vs- ipsilateral surgery (TORS/ND).

0 / 15Eligibility criteria met