Description:
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.
Title
- Brief 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
- 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
Clinical Trial IDs
- ORG STUDY ID:
UPCC 40313
- NCT ID:
NCT02159703
Conditions
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Single Arm Phase 2 | Experimental | | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Percentage of Participants With Local Control |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Abramson Cancer Center of the University of Pennsylvania |
Trial Keywords
- T1-2 N2 M0,
- stage IVa SCCA
- oropharynx
- negative for PNI,
- negative surgical margins
Last Updated
November 21, 2019