A Single-arm Phase II Study of Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) to the Regional Nodes for Advanced Stage, Human Papilloma Virus (HPV) Positive, Oropharyngeal Cancer



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/2/2017
Start Date:February 2014
Contact:Alexander Lin, MD
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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To determine 2-year local (primary tumor site) control and toxicity rates in patients
receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely
resected, HPV-positive SCCA of the oropharynx.

To determine acute and long-term toxicity rates in patients receiving adjuvant RT post-TORS,
omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of
the oropharynx.


Inclusion Criteria:

- Patients 18 years or older Histologically confirmed diagnosis of squamous cell
carcinoma of the oropharynx, stage IVa, p16-positive on immunohistochemistry
Pathologic T1 or T2 disease, resected with negative margins ( 2mm) Pathologic N2a,
N2b, or N2c disease ECOG Performance Status 0-1

- Patients must sign an informed consent document that indicates they are aware of the
investigational nature of the treatment in this protocol as well as the potential
risks and benefits - - - Ability to understand and the willingness to provide written
informed consent

Exclusion Criteria

- Prior radiation therapy to the head and neck Prior chemotherapy within the past 5
years Presence of T3 or T4 disease Presence of close (2 mm) or positive margins PNI on
TORS resection of the primary cancer Presence of N0 or N1 disease in neck dissection
Presence of distant metastatic (M1) disease

- Uncontrolled intercurrent illness including, but not limited to, symptomatic
congestive heart failure, unstable angina pectoris, connective tissue disease or
psychiatric illness/social situations that would limit compliance with study
requirements.
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Philadelphia, PA
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