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

Primary Purpose

Head and Neck Cancer, Head and Neck Carcinoma, Head and Neck Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-FMISO PET/CT scan
Chemoradiation therapy
Carboplatin
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Unknown Primary Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, fluoromisonidazole, 18F-FMISO, Memorial Sloan Kettering Cancer Center, 22-227

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with Squamous Cell Carcinoma Head and Neck Cancer

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants alive post-Chemo Radiation Therapy
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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2022
Last Updated
May 26, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05544136
Brief Title
A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer
Official Title
A Pilot Study of Radiation De-Escalation for p16 Negative Oropharyngeal Cancer and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
March 12, 2027 (Anticipated)
Study Completion Date
March 12, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Head and Neck Carcinoma, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
Keywords
Unknown Primary Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, fluoromisonidazole, 18F-FMISO, Memorial Sloan Kettering Cancer Center, 22-227

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with Squamous Cell Carcinoma Head and Neck Cancer
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-FMISO PET/CT scan
Intervention Description
18F-FMISO PET/CT scan (only 1 injection) that occurs 5-10 treatment days after RT start
Intervention Type
Radiation
Intervention Name(s)
Chemoradiation therapy
Other Intervention Name(s)
CRT
Intervention Description
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
Drug
Intervention Name(s)
Carboplatin
Intervention Description
The chemotherapy used in this protocol is the standard of care for head and neck cancer, cisplatin or carboplatin/5-Fluorouracil
Primary Outcome Measure Information:
Title
Number of participants alive post-Chemo Radiation Therapy
Description
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.
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaveh Zakeri, MD
Phone
848-225-6435
Email
ZakeriK@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Sherman, MD
Phone
646-608-3776
Email
shermane@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
646-888-4184
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
848-225-6435
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
646-888-4184
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
646-888-4184
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
646-888-4184
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaveh Zakeri, MD
Phone
646-888-4184

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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