RECRUITING

A Study of Decreasing Radiation Therapy and Chemotherapy in People with Head and Neck Cancer

Conditions

Head and Neck Cancer Head and Neck Carcinoma Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Unknown Primary Squamous Cell Carcinoma fluoromisonidazole 18F-FMISO Memorial Sloan Kettering Cancer Center 22-227

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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 purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. The study will look at how effective the treatment approach is against participants' cancer.

Official Title

A Pilot Study of Radiation De-Escalation for P16 Negative Oropharyngeal Cancer and P16-Negative or Positive Laryngeal and Hypopharyngeal Cancers

Quick Facts

Study Start:2022-09-12

Study Completion:2027-03-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05544136

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
* Histologically confirmed diagnosis of SCC of the head and neck (excluding nasopharynx, nasal cavity/paranasal sinus, oral cavity, salivary, thyroid, and cutaneous primary malignancies). * Any unknown primary SCC of the head and neck with radiographically detectable gross nodes is allowed (core or excisional biopsy acceptable; if excisional biopsy is performed, there must be residual radiographically detectable nodal disease; FNA may be acceptable only with PI and/or co-PI approval) * If the primary site is oropharynx or unknown primary, P16 IHC must be negative. * If the primary site is hypopharynx or larynx, any P16 status is acceptable (positive, negative, or unknown). P16 IHC is strongly encouraged when possible. * Clinical stage T0-3 N1-2C M0 (AJCC 7th edition) without evidence of distant metastasis based on staging FDG PET/CT. * 18 years of age or older. * Must not have received prior radiation therapy or chemotherapy for HNC. * Patients who have had their primary site tumor removed by surgery but still have residual grossly enlarged, radiographically detectable lymph nodes are eligible for this study. * Karnofsky Performance Status (KPS) ≥ 70. * CT or MRI of the Neck with and without contrast * Adequate hematologic function within 30 days prior to registration, defined as follows: * White Blood Count (WBC) ≥ 2,000 cells/µL * 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 interventions 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 (CrCl) ≥ 50 mL/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = \[(140 - age) x (weight in kg)\] / \[(Serum Cr mg/dL) x (72)\] CrCl female = 0.85 x (CrCl male) * Patients with serum creatinine \> 1.5 mg/dL can be eligible for carboplatin-based chemotherapy with approval of co-PI (Dr. Eric Sherman * Adequate hepatic function within 30 days prior to registration, defined as follows: * Bilirubin \< 2 mg/dL * AST or ALT \< 3 x the upper limit of normal * Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential. * The subject/legally authorized representative (LAR) must provide study-specific informed consent prior to study entry.	* All nasopharyngeal, nasal cavity/paranasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies. * Any T4 or N3 patients * Any prior radiotherapy to the head and neck region. * Any prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different non-H\&N cancer is permissible. * Prior chemotherapy or radiotherapy within the last three years. * Patients who underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged, radiographically detectable lymph nodes). * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years estimated to be ≥ 90%. * Subjects with simultaneous primary cancers outside of the oropharynx * Pregnant (confirmed by serum b-HCG in women of reproductive age) or breastfeeding. * Severe, active co-morbidities 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

* Histologically confirmed diagnosis of SCC of the head and neck (excluding nasopharynx, nasal cavity/paranasal sinus, oral cavity, salivary, thyroid, and cutaneous primary malignancies).
* Any unknown primary SCC of the head and neck with radiographically detectable gross nodes is allowed (core or excisional biopsy acceptable; if excisional biopsy is performed, there must be residual radiographically detectable nodal disease; FNA may be acceptable only with PI and/or co-PI approval)
* If the primary site is oropharynx or unknown primary, P16 IHC must be negative.
* If the primary site is hypopharynx or larynx, any P16 status is acceptable (positive, negative, or unknown). P16 IHC is strongly encouraged when possible.
* Clinical stage T0-3 N1-2C M0 (AJCC 7th edition) without evidence of distant metastasis based on staging FDG PET/CT.
* 18 years of age or older.
* Must not have received prior radiation therapy or chemotherapy for HNC.
* Patients who have had their primary site tumor removed by surgery but still have residual grossly enlarged, radiographically detectable lymph nodes are eligible for this study.
* Karnofsky Performance Status (KPS) ≥ 70.
* CT or MRI of the Neck with and without contrast
* Adequate hematologic function within 30 days prior to registration, defined as follows:
* White Blood Count (WBC) ≥ 2,000 cells/µL
* 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 interventions 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 (CrCl) ≥ 50 mL/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = \[(140 - age) x (weight in kg)\] / \[(Serum Cr mg/dL) x (72)\] CrCl female = 0.85 x (CrCl male)
* Patients with serum creatinine \> 1.5 mg/dL can be eligible for carboplatin-based chemotherapy with approval of co-PI (Dr. Eric Sherman
* Adequate hepatic function within 30 days prior to registration, defined as follows:
* Bilirubin \< 2 mg/dL
* AST or ALT \< 3 x the upper limit of normal
* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential.
* The subject/legally authorized representative (LAR) must provide study-specific informed consent prior to study entry.

* All nasopharyngeal, nasal cavity/paranasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies.
* Any T4 or N3 patients
* Any prior radiotherapy to the head and neck region.
* Any prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different non-H\&N cancer is permissible.
* Prior chemotherapy or radiotherapy within the last three years.
* Patients who underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged, radiographically detectable lymph nodes).
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years estimated to be ≥ 90%.
* Subjects with simultaneous primary cancers outside of the oropharynx
* Pregnant (confirmed by serum b-HCG in women of reproductive age) or breastfeeding.
* Severe, active co-morbidities 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

Eric Sherman, MD

CONTACT

646-608-3776

shermane@mskcc.org

Principal Investigator

Nancy Lee, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at 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 Cancer Center @ 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

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 Date2022-09-12

Study Completion Date2027-03-12

Study Record Updates

Study Start Date2022-09-12

Study Completion Date2027-03-12

Terms related to this study

Keywords Provided by Researchers

Unknown Primary Squamous Cell Carcinoma
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
fluoromisonidazole
18F-FMISO
Memorial Sloan Kettering Cancer Center
22-227

Additional Relevant MeSH Terms

Head and Neck Cancer
Head and Neck Carcinoma
Head and Neck Neoplasms
Head and Neck Squamous Cell Carcinoma