Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy

Washington University School of Medicine1 site in 1 country74 target enrollmentApril 11, 2007

ConditionsCancer of the Larynx

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cancer of the Larynx
Sponsor: Washington University School of Medicine
Enrollment: 74
Locations: 1
Primary Endpoint: Number of Participants With a Recurrence in the Unirradiated Neck(s)
Status: Active, Not Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if reducing or eliminating radiation treatment to one or both sides of the neck where there is no evidence of cancer can help spare the side effects of radiation treatment for head and neck cancer. In this study, the investigators plan to reduce the amount of radiation treatment received to healthy tissue

Registry

clinicaltrials.gov

Start Date

April 11, 2007

End Date

April 30, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

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 N
•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

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.

Outcomes

Primary Outcomes

Number of Participants With a Recurrence in the Unirradiated Neck(s)

Time Frame: 12 months of follow-up

* Recurrence in a PN0 neck that was not treated is the critical endpoint in this study. * Recurrence is defined as the return of cancer after treatment * Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease.

Secondary Outcomes

Quality of Life (QOL) as Measured by Xerostomia QOL Data(Median follow-up was 22 months)
Kaplan Meier Estimate of Locoregional Recurrence Free Survival(3 years)
Disease Specific Survival Rate(Completion of follow-up (minimum of 5 years from completion of treatment))
Kaplan Meier Estimate of Overall Survival(3 years)
Quality of Life (QOL) as Measured by Overall Global QOL Scores(Median follow-up was 22 months)
Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms(Completion of follow-up (minimum of 5 years from completion of treatment))
Patterns of Failure Associated With Implementation of Primary Objective(Completion of follow-up (minimum of 5 years from completion of treatment))