Overview

A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer

Status:
Recruiting
Trial end date:
2024-08-04
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Treatments:
Carboplatin
Fluorouracil
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.

a. 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

- Subjects must have clinically or radiographically evident measurable gross disease at
either the primary tumor site or nodal stations.

- Clinical stage T1-3/N1-2c, T2-3/N0-2c, T0/N1-N2c (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

- 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:

a. 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)

- 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

- 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:

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