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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05544136
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 18F-FMISO PET/CT scan
  • Radiation: Chemoradiation therapy
  • Drug: Carboplatin
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Radiation and Chemotherapy De-Escalation for p16-Negative Oropharyngeal Cancer and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers
Actual Study Start Date :
Sep 12, 2022
Anticipated Primary Completion Date :
Mar 12, 2024
Anticipated Study Completion Date :
Mar 12, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants with Small 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

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

Radiation: 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.
Other Names:
  • CRT
  • Drug: Carboplatin
    The chemotherapy used in this protocol is the standard of care for head and neck cancer, cisplatin or carboplatin/5-Fluorouracil

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants alive post-Chemo Radiation Therapy [2.5 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 N1-2B 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey United States 07920
    2 Memoral Sloan Kettering Monmouth (Limited Protocol Activities) Middletown New Jersey United States 07748
    3 Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey United States 07645
    4 Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) Commack New York United States 11725
    5 Memoral Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York United States 10604
    6 Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York United States 10065

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Principal Investigator: Kaveh Zakeri, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05544136
    Other Study ID Numbers:
    • 22-227
    First Posted:
    Sep 16, 2022
    Last Update Posted:
    Sep 16, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Memorial Sloan Kettering Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 16, 2022