Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy
18 Years
N/A
Both
Cancer of the Larynx
Trial Information
Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy
The proposed study will prospectively test whether this method of volume reduction can be
implemented without a change in the historical institutional locoregional control rate
achieved with intensity modulated postoperative radiation therapy (IMPORT). Quality of life
measurements via validated instruments will be incorporated to establish correlation of
volume reduction with QOL.
Inclusion Criteria:
- Patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or
hypopharynx .
- Treated with surgical resection with one (or both) side(s) of the neck pathologically
N0.
- Indication for radiation therapy at the primary site or neck consisting of any of the
below characteristics:
- Close margin (<= 0.5 cm)
- Positive margin
- Perineural invasion
- Lymphovascular space invasion
- Metastatic disease in more than one lymph node
- Metastatic disease in more than one lymph node group
- Extracapsular extension in any lymph node
- Constellation of factors considered to be at risk based on the
multi-disciplinary tumor board discussion.
- Age >= 18.
- Patients must sign study specific, IRB-approved consent form.
Exclusion Criteria:
- Previous head and neck cancer other than non melanoma skin cancer.
- Previous head and neck surgery.
- Female patients who are pregnant or nursing.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Eliminate radiation of PN0 neck(s) and demonstrate >90% control in the unirradiated neck(s)
Outcome Description:
Recurrence in a PN0 neck that was not treated is the critical endpoint in this study.
Outcome Time Frame:
12 months of follow-up
Safety Issue:
No
Principal Investigator
Wade Thorstad, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Washington University School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
07-0142 / 201106342
NCT ID:
NCT00593840
Start Date:
April 2007
Completion Date:
February 2014
Related Keywords:
- Cancer of the Larynx
- Laryngeal Neoplasms
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
