Home › Trials › NCT05544136

Reducing radiation and chemotherapy for head and neck cancer treatment

A Pilot Study of Radiation De-Escalation for p16 Negative Oropharyngeal Cancer and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers

Phase 2 Interventional Memorial Sloan Kettering Cancer Center · NCT05544136

This study is testing if giving less radiation and chemotherapy before surgery can still effectively treat certain head and neck cancers while reducing side effects for patients.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment12 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionschemotherapy, radiation
Locations6 sites (Basking Ridge, New Jersey and 5 other locations)
Trial IDNCT05544136 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate a treatment approach that involves decreasing the amount of radiation therapy and chemotherapy in patients with head and neck cancer, followed by planned neck dissection surgery. Participants will undergo an 18F-FMISO PET/CT scan to assess the effectiveness of this de-escalated treatment strategy against their cancer. The study focuses on patients with specific types of head and neck squamous cell carcinoma, particularly those with radiographically detectable nodes. The goal is to determine if this approach can maintain treatment efficacy while potentially reducing side effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed head and neck squamous cell carcinoma and specific staging criteria.

Not a fit: Patients who have previously received radiation therapy or chemotherapy for head and neck cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to less aggressive treatment regimens for patients with head and neck cancer, minimizing side effects while maintaining effectiveness.

How similar studies have performed: Other studies have explored de-escalation strategies in cancer treatment, showing promising results, but this specific approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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

  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.

Where this trial is running

Basking Ridge, New Jersey and 5 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Head and Neck CancerHead and Neck CarcinomaHead and Neck NeoplasmsHead and Neck Squamous Cell CarcinomaUnknown Primary Squamous Cell Carcinomafluoromisonidazole18F-FMISOMemorial Sloan Kettering Cancer Center
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.