RECRUITING

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)

Conditions

HPV Oropharynx Cancer HPV-Related Carcinoma HPV-Related Malignancy HPV Positive Oropharyngeal Squamous Cell Carcinoma ctDNA NavDx test 21-434 HPV-OPC Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-24

Study Completion:2025-03-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05307939

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 * ECOG 0-2 * HPV-16 squamous cell carcinoma of the oropharynx or HPV-16 head and neck squamous cell carcinoma of unknown primary . HPV status must be confirmed by in-situ hybridization. * HPV ctDNA detectable by HPV digital PCR (Naveris assay) with a minimum of 50 copies/mL pre-operatively. * Surgical resection of all gross disease with no gross disease visualized on post-operative imaging. * Two, undetectable (\<1 copy/mL) post-operative HPV ctDNA within 2-6 weeks following surgery (blood drawn at least one week apart preferred). * A minimum of one of the following pathologic criteria: (Arm A) * AJCC 7 Stage: pT0N1-N2b, pT1N1, pT2N1, or ≥pT3 * AJCC 7 ≥pN2 * Lymphovascular invasion * Perineural invasion * Close pathologic margin (≤ 3 mm) * Signed informed consent form by the participant or their legally authorized representative (LAR). * A minimum of one of the following pathologic criteria (Arm B): * Microscopic positive margin * Extracapsular extension * Signed informed consent form by the participant or their legally authorized representative (LAR). * Adequate hematologic function within 30 days prior to registration, defined as follows: * White Blood Count (WBC) ≥ 2 K/mcL * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 * Platelets ≥ 100,000 cells/mm3 * Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable * Adequate renal function within 30 days prior to registration, defined as follows: * Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: * CCr male = \[(140 - age) x (wt in kg)\] divided by \[(Serum Cr mg/dl) x (72)\] * CCr female = 0.85 x (CrCl male) * Adequate hepatic function within 30 days prior to registration, defined as follows: * Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential	* Metastatic disease * Non-HPV16 genotype (i.e. HPV-18,-31, -33, -35) * Patients who receive surgery at outside institution. Exceptions can be made for high-volume surgical centers at the discretion of the PI/co-PI * Prior head and neck radiation * Patients without pre-operative HPV ctDNA or pre-operative HPV ctDNA ≤ 50 copies/mL * Subjects with simultaneous primary cancers outside of the oropharynx * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years is 90% or greater * Prior systemic chemotherapy for the study cancer * 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.

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18
* ECOG 0-2
* HPV-16 squamous cell carcinoma of the oropharynx or HPV-16 head and neck squamous cell carcinoma of unknown primary . HPV status must be confirmed by in-situ hybridization.
* HPV ctDNA detectable by HPV digital PCR (Naveris assay) with a minimum of 50 copies/mL pre-operatively.
* Surgical resection of all gross disease with no gross disease visualized on post-operative imaging.
* Two, undetectable (\<1 copy/mL) post-operative HPV ctDNA within 2-6 weeks following surgery (blood drawn at least one week apart preferred).
* A minimum of one of the following pathologic criteria: (Arm A)
* AJCC 7 Stage: pT0N1-N2b, pT1N1, pT2N1, or ≥pT3
* AJCC 7 ≥pN2
* Lymphovascular invasion
* Perineural invasion
* Close pathologic margin (≤ 3 mm)
* Signed informed consent form by the participant or their legally authorized representative (LAR).
* A minimum of one of the following pathologic criteria (Arm B):
* Microscopic positive margin
* Extracapsular extension
* Signed informed consent form by the participant or their legally authorized representative (LAR).
* Adequate hematologic function within 30 days prior to registration, defined as follows:
* White Blood Count (WBC) ≥ 2 K/mcL
* Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
* Platelets ≥ 100,000 cells/mm3
* Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable
* Adequate renal function within 30 days prior to registration, defined as follows:
* Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula:
* CCr male = \[(140 - age) x (wt in kg)\] divided by \[(Serum Cr mg/dl) x (72)\]
* CCr female = 0.85 x (CrCl male)
* Adequate hepatic function within 30 days prior to registration, defined as follows:
* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential

* Metastatic disease
* Non-HPV16 genotype (i.e. HPV-18,-31, -33, -35)
* Patients who receive surgery at outside institution. Exceptions can be made for high-volume surgical centers at the discretion of the PI/co-PI
* Prior head and neck radiation
* Patients without pre-operative HPV ctDNA or pre-operative HPV ctDNA ≤ 50 copies/mL
* Subjects with simultaneous primary cancers outside of the oropharynx
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years is 90% or greater
* Prior systemic chemotherapy for the study cancer
* 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.

Contacts and Locations

Study Contact

Linda Chen, MD

CONTACT

201-775-7447

chenl1@mskcc.org

Nancy Lee, MD

CONTACT

212-639-3341

leen2@MSKCC.ORG

Principal Investigator

Linda Chen, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited protocol activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activites)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Linda Chen, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-24

Study Completion Date2025-03-24

Study Record Updates

Study Start Date2022-03-24

Study Completion Date2025-03-24

Terms related to this study

Keywords Provided by Researchers

ctDNA
NavDx test
21-434
HPV-OPC
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

HPV
Oropharynx Cancer
HPV-Related Carcinoma
HPV-Related Malignancy
HPV Positive Oropharyngeal Squamous Cell Carcinoma