Recruiting
Phase 2

Radiation Therapy & Chemotherapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05544136

Conditions

Head and Neck Cancer

Head and Neck Carcinoma

Head and Neck Neoplasms

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-FMISO PET/CT scan

Chemoradiation therapy

Carboplatin

Study Details

Brief summary:

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.

Conditions

Head and Neck Cancer

Head and Neck Carcinoma

Head and Neck Neoplasms

Head and Neck Squamous Cell Carcinoma

Study ID

NCT05544136

Start date

Sep 12, 2022

Status verified date

Aug, 2026

Completion date

Mar 12, 2027

Anticipated

Primary completion date

Mar 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

o Note: A CT scan of the Neck and/or a PET/CT performed for the purposes of radiation planning may serve as planning tools.
  • 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.

Exclusion Criteria:

  • All nasopharyngeal, nasal cavity/paranasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies.
  • Any 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

o Note: Exceptions can be made for patients with simultaneous primaries outside the H\&N if determined by the PI/Co-PI that the patient can proceed with protocol activities.
  • 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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with Squamous Cell Carcinoma Head and Neck Cancer

Participants will be hypoxia-negative T0-3N1-2B small cell carcinoma head and neck cancer/SCC HNC patients (HPV-OPC, HPV- UPC with nodal metastasis(es), HPC, or LXC) who are eligible for definitive CRT with de-escalated radiation concurrent with 2 cycles of SOC chemotherapy. Hypoxia status will be determined by the absence of hypoxia radiotracer uptake on 18F-FMISO PET/CT imaging

Interventions

18F-FMISO PET/CT scan

18F-FMISO PET/CT scan (only 1 injection) that occurs 5-10 treatment days after RT start

Chemoradiation therapy

  • 18F-FMISO hypoxia negative patients complete CRT with 70Gy primary tumor and 50Gy de-escalated RT dose to gross nodes (if 50Gy is has pilot efficacy, then 44Gy to gross nodes; if 44Gy has pilot efficacy, then 40Gy to gross nodes).
  • 18F-FMISO hypoxia positive patients are taken off study and complete SOC 70Gy CRT to primary tumor and gross nodes.

Carboplatin

The chemotherapy used in this protocol is the standard of care for head and neck cancer, cisplatin or carboplatin/5-Fluorouracil

Primary outcome measure

  • Number of participants alive post-Chemo Radiation Therapy [ Time Frame: 2.5 years ]

Central Contacts and Locations

Central contacts

Zeinab Abou Yehia, MD

212-639-3960abouyez@mskcc.org

Eric Sherman, MD

646-608-3776shermane@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Zeinab Abou Yehia, MD

212-639-3960

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Zeinab Abou Yehia, MD

212-639-3960

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Zeinab Abou Yehia, MD

212-639-3960

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Zeinab Abou Yehia, MD

212-639-3960

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Zeinab Abou Yehia, MD

212-639-3960

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Zeinab Abou Yehia, MD

212-639-3960

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-12.