30 Participants Needed

ctDNA Testing for Oropharyngeal Cancer

Recruiting at 6 trial locations
LC
NL
AS
Overseen ByAcharf Shamseddine, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a blood test to detect tiny pieces of HPV DNA in people with throat cancer who have had surgery. The goal is to see if this test can help decide if and when they need more treatment like radiation or chemotherapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is ctDNA testing for oropharyngeal cancer safe for humans?

The research does not provide specific safety data for ctDNA testing in humans, but it is being actively studied as a promising tool for monitoring and diagnosing HPV-related oropharyngeal cancer.12345

How is the ctDNA Testing for Oropharyngeal Cancer treatment different from other treatments?

This treatment is unique because it uses circulating tumor DNA (ctDNA) as a biomarker to monitor the response to therapy and detect disease recurrence in HPV-related oropharyngeal cancer. This approach allows for more personalized treatment adjustments, potentially improving outcomes and reducing unnecessary side effects compared to traditional methods.12345

What data supports the effectiveness of this treatment for oropharyngeal cancer?

Research shows that circulating tumor DNA (ctDNA) is a promising biomarker for monitoring and predicting treatment response in HPV-related oropharyngeal cancer. It can help in early diagnosis, assess treatment effectiveness, and detect disease recurrence, potentially improving patient outcomes.12345

Who Is on the Research Team?

AS

Acharf Shamseddine, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My post-surgery HPV cancer tests were negative twice.
My cancer has spread beyond its original location or has cells at the surgery margin.
Signed informed consent form by the participant or their legally authorized representative (LAR).
See 7 more

Exclusion Criteria

Severe, active co-morbidity defined as follows: - Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months - Transmural myocardial infarction within the last 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of registration - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.
My cancer has spread to other parts of my body.
I have cancer in areas other than the oropharynx.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Surveillance

Monitoring of HPV ctDNA levels to determine the need for radiation therapy

Up to 4 weeks
Regular monitoring visits

Treatment (Arm A)

Delayed standard of care adjuvant radiation based on HPV ctDNA levels

50-60 Gy administered in 1.8-2 Gy fractions
Multiple visits for radiation therapy

Treatment (Arm B)

De-escalated treatment with adjuvant radiation and concurrent chemotherapy

3 weeks
Multiple visits for radiation and chemotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Chemoradiation
  • HPV ctDNA Assay
  • Intensity-Modulated Radiation Therapy
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Screening, active surveillance, and treatment (Arm A)Experimental Treatment6 Interventions
Group II: Screening and deescalated treatment (Arm B)Experimental Treatment6 Interventions

Chemoradiation is already approved in China for the following indications:

🇨🇳
Approved in China as Baizean for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

Circulating tumor DNA (ctDNA) is a promising biomarker for diagnosing and monitoring human papillomavirus-related oropharyngeal squamous cell carcinoma, potentially improving patient management.
Changes in ctDNA levels during and after treatment may indicate disease response, which could inform decisions on whether to intensify or reduce treatment strategies.
The Current Role of Human Papillomavirus Circulating Tumor DNA in Oropharynx Cancer.Regan, SN., Mierzwa, ML.[2023]
In a study of 34 patients with stage III oropharyngeal squamous cell carcinoma, low levels of circulating tumor DNA (ctDNA) before treatment and an early increase during treatment were linked to better outcomes, indicating that ctDNA can be a useful biomarker for predicting treatment response.
The study found that ctDNA levels correlated well with imaging biomarkers from MRI and FDG-PET scans, suggesting that ctDNA and imaging metrics are similarly effective in predicting freedom from progression after chemoradiation.
Early HPV ctDNA Kinetics and Imaging Biomarkers Predict Therapeutic Response in p16+ Oropharyngeal Squamous Cell Carcinoma.Cao, Y., Haring, CT., Brummel, C., et al.[2022]
HPV-related oropharyngeal squamous cell carcinoma (OPSCC) generally has better treatment outcomes compared to non-virally mediated cancers, prompting research into strategies that reduce treatment toxicity while maintaining survival rates.
Circulating tumor (ct) DNA is a promising biomarker for monitoring treatment response and disease recurrence in head and neck cancers, particularly in HPV-related OPSCC, suggesting potential for its integration into clinical practice.
The future of circulating tumor DNA as a biomarker in HPV related oropharyngeal squamous cell carcinoma.Haring, CT., Dermody, SM., Yalamanchi, P., et al.[2022]

Citations

The Current Role of Human Papillomavirus Circulating Tumor DNA in Oropharynx Cancer. [2023]
Early HPV ctDNA Kinetics and Imaging Biomarkers Predict Therapeutic Response in p16+ Oropharyngeal Squamous Cell Carcinoma. [2022]
The future of circulating tumor DNA as a biomarker in HPV related oropharyngeal squamous cell carcinoma. [2022]
Circulating Tumor DNA in Human Papillomavirus-Mediated Oropharynx Cancer: Leveraging Early Data to Inform Future Directions. [2023]
Circulating tumor-tissue modified HPV DNA testing in the clinical evaluation of patients at risk for HPV-positive oropharynx cancer: The IDEA-HPV study. [2023]
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