RecruitingPhase 2NCT05307939

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)

Phase II Trial Evaluating Selective Minimal Residual Disease Directed Adjuvant Radiation in Human Papilloma Virus Associated Oropharynx Carcinoma

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

30 participants

Start Date

Mar 24, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study will look at whether monitoring HPV ctDNA levels is an effective way to detect cancer relapse risk in people with HPV-OPC. All participants will have recently had surgery to treat their disease, or they will be scheduled to have this surgery. In Arm A the researchers will see whether monitoring participants' HPV ctDNA levels can safely identify patients who do not need radiation therapy (RT) after surgery and whose RT can be delayed until their HPV ctDNA levels become detectable. In Arm B, the researchers will see whether patients who usually need 6-6.5 weeks of CRT can be selected by HPV ctDNA to receive 3 weeks of CRT.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a blood test that detects tiny fragments of HPV-related tumor DNA (called ctDNA) to guide when patients who had surgery for HPV-related throat cancer should start additional radiation or chemotherapy. The goal is to see if delaying or personalizing treatment based on this blood test is safe and leads to fewer side effects. **You may be eligible if...** - You are 18 or older with HPV-16 related throat (oropharynx) cancer - Your HPV ctDNA was detectable in your blood before surgery - You had surgery that removed all visible cancer - Two post-surgery blood tests (drawn at least a week apart) showed undetectable ctDNA levels - Your cancer had certain higher-risk features (such as lymph node spread, nerve involvement, or close surgical margins) **You may NOT be eligible if...** - Your ctDNA levels did not meet the required thresholds before or after surgery - You have had prior radiation to the head and neck area - You are pregnant or breastfeeding - You have serious medical conditions that would make chemotherapy or radiation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTHPV ctDNA Assay

HPV ctDNA evaluation will be completed using NavDx which is a validated digital droplet PCR (ddPCR) assay that targets primers and hydrolysis probes to specifically detect amplicons within the E6 and E7 genes encoded by high-risk HPV strain 16, and the E7 gene for high-risk HPV strains: 18, 31, 33, and 35.

DIAGNOSTIC_TESTMRI Studies

Research MRI studies will be acquired at Memorial Sloan Kettering using a fast multi-phase spoiled gradient echo sequence. A Gadolinium-based agent will be used for DCE-MRI studies.

BEHAVIORALEORTC QLQ H&N 35 and C30

The EORTC QLQ H\&N 35 s a validated 35-item site specific assessment tool. The module uses 7 multi-item scales to measure problems with swallowing, senses, speech, social eating and social contact. In addition, 11 single-item scales are utilized in assessing problems with teeth, mouth opening, dry mouth, sticky saliva, coughing, feeling ill, as well as use of analgesics, nutritional supplements, feeding tube and finally, weight gain and weight loss. All of the scales and single item measures range in score from 0 to 100. High scores for the Global Health Status/QoL scale represent high QoL, high scores for the functional scales represent high/healthy levels of functioning, but high scores for the symptom scales/items represent high levels of symptomatology/problems. Scoring the two instruments yields a total of 33 distinct scores and we will examine all of these scored.

BEHAVIORALMDADI-HN

The MDADI-HN is a questionnaire scored on a scale of 1 to 5, consisting of global, emotional, functional, and physical subscales. The MDADI-HN evaluates the effects of dysphagia on QOL.

BEHAVIORALCOST-FACIT

Comprehensive Score for financial Toxicity or COST survey is a validated screening tool to assess objective and subjective questions about treatment-related financial distress. It is scored from 0-44, where lower composite scores reflect greater risk of financial toxicity.

RADIATIONIntensity-Modulated Radiation Therapy (Arm A)

59.4-60 Gy in 1.8-2 Gy fractions: CTV\_primary, Involved/Adjacent to nodal levels. 50 Gy to this volume is allowed as per MSK institutional standards in patients with clear or close margins and 2-4 involved nodes. 45-50.4 Gy in 1.8-2 Gy fractions: Dissected node positive neck: uninvolved levels that are not adjacent to positive node - Dissected node negative neck

COMBINATION_PRODUCTChemoradiation (Arm B)

30 Gy in 2 Gy fractions: CTV\_primary, CTV\_node-positive neck, CTV\_node-negative neck, received de-escalated postoperative chemoradiation. Adjuvant radiation will be administered as previously outlined. Concurrent chemotherapy will be administered as per standard of care. Cisplatin will be administered concurrently with radiation. For non-cisplatin candidates, carboplatin/5fu will be administered. Reasons for using carboplatin/5FU instead of cisplatin need to be charted in the medical record, but the decision belongs to the treating physician. Cisplatin may be given up to 3 days before the scheduled dates, if necessary for medical or personal reasons