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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05544136
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 18F-FMISO PET/CT scan — DIAGNOSTIC_TEST
    18F-FMISO PET/CT scan (only 1 injection) that occurs 5-10 treatment days after RT start
  • Chemoradiation therapy — 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 — DRUG
    The chemotherapy used in this protocol is the standard of care for head and neck cancer, cisplatin or carboplatin/5-Fluorouracil

Study Details

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.

Key Dates

Start date
Sep 12, 2022
Status verified
Feb 2026
Primary completion
Mar 12, 2027
Completion
Mar 12, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Zeinab Abou Yehia, MD
212-639-3960
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Zeinab Abou Yehia, MD
212-639-3960
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Zeinab Abou Yehia, MD
212-639-3960
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)CommackNew York11725
Zeinab Abou Yehia, MD
212-639-3960
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Zeinab Abou Yehia, MD
212-639-3960
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Zeinab Abou Yehia, MD
212-639-3960

Find similar trials in Basking Ridge, NJ

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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