Clinical Trials /

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

NCT02159703

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.

Related Conditions:
  • Oropharyngeal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Oropharyngeal Cancer

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

NameTypeDescriptionInterventions
Single Arm Phase 2Experimental

    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:Number of Adverse Events
    Time Frame:2 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    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