Trial Title:
A Study of Decreasing Radiation Therapy and Chemotherapy in People with Head and Neck Cancer
NCT ID:
NCT05544136
Condition:
Head and Neck Cancer
Head and Neck Carcinoma
Head and Neck Neoplasms
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carboplatin
Conditions: 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
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
18F-FMISO PET/CT scan
Description:
18F-FMISO PET/CT scan (only 1 injection) that occurs 5-10 treatment days after RT start
Arm group label:
Participants with Squamous Cell Carcinoma Head and Neck Cancer
Intervention type:
Radiation
Intervention name:
Chemoradiation therapy
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.
Arm group label:
Participants with Squamous Cell Carcinoma Head and Neck Cancer
Other name:
CRT
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
The chemotherapy used in this protocol is the standard of care for head and neck cancer,
cisplatin or carboplatin/5-Fluorouracil
Arm group label:
Participants with Squamous Cell Carcinoma Head and Neck Cancer
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Email:
leen2@mskcc.org
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Email:
leen2@mskcc.org
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Email:
leen2@mskcc.org
Facility:
Name:
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Email:
leen2@mskcc.org
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Email:
leen2@mskcc.org
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Email:
leen2@mskcc.org
Start date:
September 12, 2022
Completion date:
March 12, 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05544136
http://www.mskcc.org
