Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05544136

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-27

12

Participants Needed

6

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed squamous cell carcinoma of the head and neck excluding nasopharynx, nasal cavity/paranasal sinus, oral cavity, salivary, thyroid, and cutaneous primaries
  • Unknown primary head and neck SCC with radiographically detectable gross nodes allowed
  • If primary site is oropharynx or unknown, p16 IHC must be negative; if hypopharynx or larynx, any p16 status accepted
  • Clinical stage T0-3 N1-2C M0 (AJCC 7th edition) without distant metastasis
  • 18 years of age or older
  • No prior radiation therapy or chemotherapy for head and neck cancer
  • Patients with primary tumor removed but residual grossly enlarged lymph nodes eligible
  • Karnofsky Performance Status score of 70 or higher
  • CT or MRI of the neck with and without contrast
  • Adequate hematologic function within 30 days prior to registration
  • Adequate renal function within 30 days prior to registration
  • Adequate hepatic function within 30 days prior to registration
  • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
  • Informed consent provided by subject or legally authorized representative
Not Eligible

You will not qualify if you...

  • Nasopharyngeal, nasal cavity/paranasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies
  • Any T4 or N3 stage patients
  • Prior radiotherapy to head and neck region
  • Prior systemic chemotherapy for head and neck cancer
  • Chemotherapy or radiotherapy within last three years
  • Previous surgical resection for same disease except biopsy or primary tumor removal with residual lymph nodes
  • Prior invasive malignancy unless disease free for 3 years or high cure rate
  • Simultaneous primary cancers outside oropharynx unless approved by study investigators
  • Pregnant or breastfeeding women
  • Severe active co-morbidities including recent unstable angina, heart failure hospitalization, recent myocardial infarction, active infections requiring IV antibiotics, recent severe respiratory illness, or hepatic insufficiency causing jaundice or coagulation issues

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

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

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

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Research Team

Z

Zeinab Abou Yehia, MD

CONTACT

E

Eric Sherman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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