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

NCT ID: NCT05544136

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-12
• Study Completion Date: 2027-03-12

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

18F-FMISO PET/CT scan

Intervention Type: DIAGNOSTIC_TEST

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

Chemoradiation therapy

Intervention Type: RADIATION

• 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

Intervention Type: DRUG

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

Interventions

18F-FMISO PET/CT scan

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

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: RADIATION

Carboplatin

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

Intervention Type: DRUG

Other Intervention Names

CRT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeinab Abou Yehia, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Site Status: RECRUITING

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

Commack, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zeinab Abou Yehia, MD

Role: CONTACT

abouyez@mskcc.org

212-639-3960

Eric Sherman, MD

Role: CONTACT

shermane@mskcc.org

646-608-3776

Facility Contacts

Zeinab Abou Yehia, MD

Role: primary

212-639-3960

Zeinab Abou Yehia, MD

Role: primary

212-639-3960

Zeinab Abou Yehia, MD

Role: primary

212-639-3960

Zeinab Abou Yehia, MD

Role: primary

212-639-3960

Zeinab Abou Yehia, MD

Role: primary

212-639-3960

Zeinab Abou Yehia, MD

Role: primary

212-639-3960

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

22-227

Identifier Type: -

Identifier Source: org_study_id