RECRUITING

A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer

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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

The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following: * Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy * How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.

Official Title

Phase III Randomized and Double-blinded Trial of De-escalated Radiation in FMISO PET-selected Good Risk Versus Standard of Care Radiation in Unselected HPV Positive Oropharyngeal Cancer

Quick Facts

Study Start:2024-08-19

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06563479

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
* Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) or squamous cell carcinoma with an unknown primary. Surgical removal of primary site is allowed. * Patients must test positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization (RNAscope® 2.5 HD Reagent kit (Advanced Cell Diagnostics, Inc, Hayward, CA). Any CLIA certified testing method can be used. * Clinical stage T0-2, N1-2c (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT. Upfront clarity in staging for both editions is needed to ensure eligibility. * ECOG Performance Status of 0-1 or KPS \>/=70 * Age ≥ 18 * Adequate hematologic function within 30 days prior to registration, defined as follows: * White Blood Count (WBC) ≥ 2 K/mcL * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3 * Platelets ≥ 100,000 cells/mm\^3 * Hemoglobin ≥ 10.0 g/dl * Adequate renal 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 * The patient must provide study-specific informed consent prior to study entry	* Patients with prior head and neck radiation therapy where there is \>30% overlap with the current head and neck radiation fields. Exceptions can be made if determined by the PI/Co-PI that the patient can proceed with protocol activities * Patients whose tumors are borderline T4 based on anterior tumor extension to the extrinsic muscles of the tongue * Patients 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 to be 90% or greater * Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable * No particle therapy * Patients who are deemed non-compliant to all the protocol related activities * Contraindications to receive either cisplatin or the combination of carboplatin/5-fluorouracil at the prescribed doses. * 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 or precluding study therapy within 30 days of registration * Hepatic Insufficiency resulting in clinical jaundice and/or coagulation defects

Inclusion Criteria

Exclusion Criteria

* Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) or squamous cell carcinoma with an unknown primary. Surgical removal of primary site is allowed.
* Patients must test positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization (RNAscope® 2.5 HD Reagent kit (Advanced Cell Diagnostics, Inc, Hayward, CA). Any CLIA certified testing method can be used.
* Clinical stage T0-2, N1-2c (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT. Upfront clarity in staging for both editions is needed to ensure eligibility.
* ECOG Performance Status of 0-1 or KPS \>/=70
* Age ≥ 18
* Adequate hematologic function within 30 days prior to registration, defined as follows:
* White Blood Count (WBC) ≥ 2 K/mcL
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* Hemoglobin ≥ 10.0 g/dl
* Adequate renal 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
* The patient must provide study-specific informed consent prior to study entry

* Patients with prior head and neck radiation therapy where there is \>30% overlap with the current head and neck radiation fields. Exceptions can be made if determined by the PI/Co-PI that the patient can proceed with protocol activities
* Patients whose tumors are borderline T4 based on anterior tumor extension to the extrinsic muscles of the tongue
* Patients 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 to be 90% or greater
* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
* No particle therapy
* Patients who are deemed non-compliant to all the protocol related activities
* Contraindications to receive either cisplatin or the combination of carboplatin/5-fluorouracil at the prescribed doses.
* 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 or precluding study therapy within 30 days of registration
* Hepatic Insufficiency resulting in clinical jaundice and/or coagulation defects

Contacts and Locations

Study Contact

Nancy Lee, MD

CONTACT

212-639-3341

leen2@mskcc.org

Nadeem Riaz, MD

CONTACT

646-888-3495

Principal Investigator

Nancy Lee, 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 Activities)

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)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Nancy Lee, 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 Date2024-08-19

Study Completion Date2027-08

Study Record Updates

Study Start Date2024-08-19

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

oropharynx
tonsil
base of the tongue
oropharyngeal walls
radiation treatments
cisplatin
24-200

Additional Relevant MeSH Terms

HPV-Related Squamous Cell Carcinoma