Major Radiation Reduction for HPV+ Oropharyngeal Carcinoma



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:October 16, 2017
End Date:October 2020
Contact:Nancy Lee, MD
Email:leen2@mskcc.org
Phone:212-639-3341

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A Prospective Non-inferiority Trial of Major Radiation Dose De-Escalation Concurrent With Chemotherapy for Human Papilloma Virus Associated Oropharyngeal Carcinoma

The purpose of this study is to demonstrate that participants with HPV positive and hypoxia
negative T1-@N / 1-2b oropharyngeal squamous cell carcinoma receiving a major de-escalated
radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable
subjects treated with the current standard chemoradiation.


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 surgical resection or excisional biopsy regardless of margin status.

° Squamous cell carcinoma of the neck of unknown primary is allowed with excision
biopsy of a lymph node (or core biopsy) and consent from the PI or co-PIs (Dr. Nancy
Lee, Dr. Eric Sherman, or Dr. Nadeem Riaz)

- Subjects must have clinically or radiographically evident measurable disease at nodal
stations.

- Clinical stage T1-2, N1-2c without evidence of distant metastasis based on FDG PET/CT.

°Patients who have squamous cell carcinoma of the neck of unknown primary, and thus,
are T0, are allowed with excision biopsy of a lymph node (or core biopsy) or consent
from the PI or co-PI

- 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

- Age ≥ 18

- Adequate hematologic function within 30 days prior to registration, defined as
follows:

- White Blood Count (WBC) >/= 2 K/mcL

- 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 intervention 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 (CC) ≥ 50 ml/min determined by
24-hour collection or estimated by Cockcroft-Gault formula

- 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 must provide study-specific informed consent prior to study entry

Exclusion Criteria:

- Subjects with T3 or higher and N3 disease

- Subjects with prior head and neck radiation therapy

- Subjects with simultaneous primary cancers outside of the oropharynx

- 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

- No particle therapy such as but not limited to proton therapy is allowed

- Severe, active co-morbidity 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
We found this trial at
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480 Red Hill Road
Middletown, New Jersey 07748
Phone: 212-639-3341
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
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Commack, New York 11725
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Harrison, New York
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225 Summit Avenue
Montvale, New Jersey 07645
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-3341
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Rockville Centre, New York 11570
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Uniondale, New York 11553
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