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Radiation

Arm 1- Ipsilateral 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs)

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,234 Total Patients Enrolled

David Rosenthal, MDPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

1,136 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Arm 1- Ipsilateral?

"After careful consideration, the safety of Arm 1- Ipsilateral was estimated to be a 2 due to it being in Phase 2. This designates that there is data available regarding its security but no evidence has been found concerning performance yet."

Answered by AI

Is enrollment for this scientific trial still available?

"According to the information available on clinicaltrials.gov, this particular medical study is not presently taking part in patient recruitment. Originally posted on April 20th 2024 and last updated December 4th 2023, it has since ceased its search for participants; however, there are still 2,633 other trials actively welcoming patients at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery and/or Radiotherapy (LONE-RANGR2)

2024. "Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery and/or Radiotherapy (LONE-RANGR2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06167291.

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