Trial Title:
A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer
NCT ID:
NCT05491512
Condition:
HPV
Throat Cancer
Oropharyngeal Carcinoma
Oropharyngeal Cancer
Human Papilloma Virus
Conditions: Official terms:
Carcinoma
Papilloma
Oropharyngeal Neoplasms
Carboplatin
Fluorouracil
Conditions: Keywords:
HPV-Positive Throat Cancer
HPV
Throat Cancer
Human Papilloma Virus
Oropharyngeal Carcinoma
Oropharyngeal Cancer
Radiation Therapy
22-215
Memorial Sloan Kettering Cancer Center
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
18 F-FMISO PET/CT
Description:
The 18F-FMISO PET/CT Scan Protocol consists first of an IV bolus injection of
approximately 5-10 mCi of the radiotracer. At between 150-180 mins post injection,
18F-FMISO images will be acquired.
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort D
Intervention type:
Radiation
Intervention name:
Radiation
Description:
Total Radiation Dose (over 3 weeks) 30Gy** in 2 Gy per fraction
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort D
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Concurrent chemotherapy (2 cycles) will be given. At the start of week 1 of radiation,
subjects will receive cisplatin 100 mg/m2 intravenously. They may be given for 2
consecutive days (50 mg/m2 each day for a total dose 100 mg/m2 ), typically on days 1 and
2, or as a single dose, typically on day 1.
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort D
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
If cisplatin cannot be given at 100 mg/m2 for either cycle 1 or cycle 2, the investigator
may use a regimen with carboplatin and 5-Fluorouracil in its place. Carboplatin will be
given at a dose of AUC 1.25 intravenously daily x 4 days starting on day 1 of the cycle
(total dose of AUC 5). 5-Fluorouracil will be given at a dose of 600 mg/m2 intravenous
infusion over 24 hours daily x 4 days (total dose of 2400 mg/m2 intravenous infusion over
96 hours).
(Cohort B to start carboplatin (AUC 1.5) and paclitaxel 45 mg/m2 at the start of RT)
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort D
Intervention type:
Drug
Intervention name:
5-fluorouracil
Description:
If cisplatin cannot be given at 100 mg/m2 for either cycle 1 or cycle 2, the investigator
may use a regimen with carboplatin and 5-Fluorouracil in its place. Carboplatin will be
given at a dose of AUC 1.25 intravenously daily x 4 days starting on day 1 of the cycle
(total dose of AUC 5). 5-Fluorouracil will be given at a dose of 600 mg/m2 intravenous
infusion over 24 hours daily x 4 days (total dose of 2400 mg/m2 intravenous infusion over
96 hours).
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort D
Summary:
The purpose of this study is to find out if lower doses of radiation may help reduce the
side effects of radiation therapy in combination with standard-of-care chemotherapy in
people with HPV-positive throat cancer. The chemotherapy drugs used in this study include
cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane-
(Albumin-bound Paclitaxel).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of HPV associated
squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal
walls) from biopsy, surgical resection or excisional biopsy regardless of margin
status.
1. Squamous cell carcinoma of the neck of unknown primary is allowed with excision
biopsy of a lymph node (or core biopsy) or consent from the PI or co-PI
2. Patient must have excisional biopsy or core biopsy done in order to be on
protocol
- Subjects must have clinically or radiographically evident measurable gross disease
at either the primary tumor site or nodal stations.
- Oropharyngeal Carcinoma (AJCC, 7th ed.) without evidence of distant metastasis based
on FDG PET/CT.
- CT or MRI of the neck with and without contrast Note: A CT scan of neck and/or a
PET/CT performed for the purposes of radiation planning may serve as planning tools.
- ECOG Performance Status of 0-2 or KPS ≥ 50
- Age ≥ 18 Patients over 70yrs will be able to enroll in Cohort B only).
- Adequate hematologic function within 30 days prior to registration, defined as
follows:
1. White Blood Count (WBC) ≥ 2 K/mcL
2. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
3. Platelets ≥ 100,000 cells/mm3
4. Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to
achieve Hgb ≥ 8.0 g/dl is acceptable
- Adequate renal function within 30 days prior to registration, defined as follows:
1. Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr
male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x
(CrCl male)
Note: Patients who cannot tolerate cisplatin or carboplatin/5FU based on clinical
judgment will receive carboplatin and paclitaxel Paclitaxel can be substituted with
Abraxane (Albumin-bound Paclitaxel).
- Adequate hepatic function within 30 days prior to registration, defined as follows:
1. Bilirubin < 2 mg/dl
2. AST or ALT < 3 x the upper limit of normal
Note: Exceptions can be made with PI and/or Co-Pi approval for patients to enroll on
trial with a higher Bilirubin level such as Gilbert's Syndrome.
Note: Patients who cannot tolerate cisplatin or carboplatin/5FU based on clinical
judgment will receive carboplatin and paclitaxel. Paclitaxel can be substituted with
Abraxane (Albumin-bound Paclitaxel).
- Negative serum pregnancy test within 14 days prior to registration for women of
childbearing potential
- The subject must provide study-specific informed consent prior to study entry
- Subject able to undergo MRI scans except for major medical contraindications like
presence of a pacemaker or approved by the PI or the CO-PI that the subject does not
need to undergo MRI scans
Exclusion Criteria:
- Subjects with prior head and neck radiation therapy
- Subjects with simultaneous primary cancers outside of the oropharynx
a. Note: Exceptions can be made for patients with simultaneous primaries outside the
oropharynx if determined by the PI/Co-PI the patient can proceed with protocol
activities.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for 3 years or if cure rate from treatment at 5 years to be 90% or greater
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable
- Severe, active co-morbidity defined as follows: (exceptions can be made if approved
by the PI and/or co-PI)
1. Unstable angina and/or congestive heart failure requiring hospitalization
within the last 6 months
2. Transmural myocardial infarction within the last 6 months
3. Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration
4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within 30 days of
registration
5. 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 Cancer Center 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
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
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
Facility:
Name:
Memorial Sloan Kettering Cancer Center at 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
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
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
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Start date:
August 4, 2022
Completion date:
August 4, 2025
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/NCT05491512
http://www.mskcc.org
