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Study of Decreasing Radiation and Chemotherapy for Head and Neck Cancer

This study is for people with certain types of head and neck cancer. It aims to test a treatment approach that uses less radiation therapy and chemotherapy (Carboplatin, or Cisplatin/5-Fluorouracil) followed by surgery to remove lymph nodes in the neck. Before treatment, you would have an 18F-FMISO PET/CT scan (a type of imaging test) to help guide the radiation dose. The main goal is to see how many participants are alive 2.5 years after completing chemoradiation therapy. The study is currently recruiting about 12 participants aged 18 and older who have a confirmed diagnosis of squamous cell carcinoma of the head and neck, excluding certain areas like the nasopharynx or oral cavity.

Study design
This is an interventional study with a planned enrollment of 12 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will undergo an 18F-FMISO PET/CT scan, receive chemoradiation therapy, and have planned neck dissection surgery. The exact duration of participation beyond treatment is not fully detailed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure how many are alive 2.5 years after completing chemoradiation therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05544136

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~12 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:18F-FMISO PET/CT scanChemoradiation therapyCarboplatin

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants alive post-Chemo Radiation Therapy
Measured over 2.5 years

Conditions

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

Explore related trials

Head and Neck Squamous Cell CarcinomaSquamous Cell Carcinoma of Unknown Primary

Where it's being run

6 sites across 2 states
New Jersey3
New York3

Study leadership

  • Zeinab Abou Yehia, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Zeinab Abou Yehia, MD
[email protected]
212-639-3960
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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
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.

What this trial measures

  • Number of participants alive post-Chemo Radiation Therapy2.5 years

    The primary objective is to assess the pilot efficacy of RT dose de-escalation to grossly involved lymph nodes for hypoxia negative T0-T3N1-2B HPV- OPC/UPC and HPC/LXC patients. For evaluation on the efficacy of the regimen in this cohort, a simple decision rule will be implemented as follows: If, among the first 10 evaluable patients, we have at least 8 patients who are alive, followed, and have major pathological response on planned neck dissection at 4 months ± 1 month post-CRT, then we will declare the treatment modality using that RT dose has pilot efficacy and will then proceed with treatment at the next de-escalated dose level.