Clinical trial NCT02159703: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oropharyngeal Cancer
Keywords: T1-2 N2 M0,
stage IVa SCCA
oropharynx
negative for PNI,
negative surgical margins
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Local Control
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Alexander Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swisher-McClure S, Lukens JN, Aggarwal C, Ahn P, Basu D, Bauml JM, Brody R, Chalian A, Cohen RB, Fotouhi-Ghiam A, Geiger G, Gershowitz J, Livolsi V, Mitra N, Montone K, Newman J, Ojerholm E, O'Malley B Jr, Rajasekaran K, Tan E, Weinstein G, Lin A. A Phase 2 Trial of Alternative Volumes of Oropharyngeal Irradiation for De-intensification (AVOID): Omission of the Resected Primary Tumor Bed After Transoral Robotic Surgery for Human Papilloma Virus-Related Squamous Cell Carcinoma of the Oropharynx. Int J Radiat Oncol Biol Phys. 2020 Mar 15;106(4):725-732. doi: 10.1016/j.ijrobp.2019.11.021. Epub 2019 Nov 27.