← Back to Search

CombinationProduct

ctDNA Testing for Oropharyngeal Cancer

Phase 2
Recruiting
Led By Linda Chen, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A minimum of one of the following pathologic criteria (Arm B): - Microscopic positive margin - Extracapsular extension
ECOG 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a way to find out if a person's HPV ctDNA levels rising after surgery means their cancer is coming back, so they can start treatment right away.

Who is the study for?
This trial is for adults with HPV-16 related oropharyngeal cancer who've had surgery to remove the tumor and show no signs of cancer in post-op imaging. They must have certain blood markers, good organ function, and be able to consent. People with metastatic disease, non-HPV16 cancers, prior chemo for this cancer, severe health issues like recent heart failure or infections can't join.Check my eligibility
What is being tested?
The study tests if monitoring cell-free tumor DNA (ctDNA) levels can guide treatment timing after surgery. Arm A explores delaying radiation therapy until ctDNA is detectable again. Arm B checks if patients normally needing longer chemoradiation could receive a shorter 3-week course based on their ctDNA levels.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions from radiation therapy such as skin irritation, fatigue, dry mouth/throat issues; and from chemotherapy like nausea/vomiting, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has spread beyond its original location or has cells at the surgery margin.
Select...
I am able to care for myself and move around.
Select...
I am 18 years old or older.
Select...
I've undergone specific tests and procedures to find the origin of my cancer, followed by surgery to remove lymph nodes in my neck.
Select...
My cancer stage or features meet specific criteria for a study group.
Select...
My test shows HPV DNA in my blood above 50 copies/mL.
Select...
My surgery removed all visible cancer, and none was seen on scans after.
Select...
My cancer is HPV-16 positive in the throat or head and neck, confirmed by a specific test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologically confirmed progression free survival

Trial Design

2Treatment groups
Experimental Treatment
Group I: Screening, active surveillance, and treatment (Arm A)Experimental Treatment6 Interventions
Participants who meet criteria for the treatment phase (a post-operative HPV ctDNA which rose from initial undetectable to meet HPV16 ctDNA criteria and have no clinical or radiographic evidence of gross disease) will undergo delayed standard of care adjuvant radiation (50-60 Gy administered in 1.8-2 Gy fractions) based on the patient's initial pathology. Treatment will be initiated within 4 weeks of a NavDx result. Subjects will undergo FDG PET/CT simulation and standard radiation treatment planning and this FDG PET/CT will also be utilized to rule out distant metastases. Diagnostic FDG PET/CT fusion is also allowed for treatment planning and to rule out distant metastases. Non-therapeutic assessments will be completed.
Group II: Screening and deescalated treatment (Arm B)Experimental Treatment6 Interventions
Participants who meet criteria for the de-escalated treatment phase (Arm B) will undergo adjuvant radiation (30 Gy administered in 2 Gy fractions) with concurrent chemotherapy. They will undergo FDG PET/CT simulation and standard radiation treatment planning and this FDG PET/CT will also be utilized to rule out distant metastases. Diagnostic FDG PET/CT fusion is also allowed for treatment planning and to rule out distant metastases. Non-therapeutic assessments will be completed and the Study calendar.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,831 Total Patients Enrolled
1 Trials studying Oropharyngeal Carcinoma
121 Patients Enrolled for Oropharyngeal Carcinoma
Linda Chen, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Chemoradiation (CombinationProduct) Clinical Trial Eligibility Overview. Trial Name: NCT05307939 — Phase 2
Chemoradiation (CombinationProduct) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05307939 — Phase 2
Oropharyngeal Carcinoma Research Study Groups: Screening and deescalated treatment (Arm B), Screening, active surveillance, and treatment (Arm A)
Oropharyngeal Carcinoma Clinical Trial 2023: Chemoradiation Highlights & Side Effects. Trial Name: NCT05307939 — Phase 2

Frequently Asked Questions

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

How many medical facilities are conducting this experiment?

"Seven medical centres are currently enrolling patients in this trial. These include Memorial Sloan Kettering Westchester (Limited Protocol Activities) located in Harrison, and Memorial Sloan Kettering Monmouth (Limited Protocol Activities) found in Middletown, as well as the Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities). Additionally, there are four other clinical sites taking part."

Answered by AI

Are there still opportunities to participate in this research initiative?

"According to clinicaltrials.gov, this experiment is currently searching for eligible participants and was originally published on March 24th 2022 with the most recent update coming April 1st 2022."

Answered by AI

Has the HPV ctDNA Assay been given authorization by the FDA?

"There is evidence suggesting the safety of HPV ctDNA Assay, thus it achieved a score of 2 on our assessment scale. This is due to its position as a Phase 2 trial, meaning there are data points that suggest safety but none indicating efficacy."

Answered by AI

To what extent has this study recruited participants?

"Affirmative. The clinicaltrials.gov page reveals that this research is actively enrolling participants, having been first posted on March 24th 2022 and latest updated April 1st 2022. Seven trial sites are recruiting 45 patients in total."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)
2022. "A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05307939.
All > Hpv
~9 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top