Overview

This trial is active, not recruiting.

Condition cancer of the larynx
Treatment imrt
Phase phase 2
Sponsor Washington University School of Medicine
Start date April 2007
End date February 2014
Trial size 74 participants
Trial identifier NCT00593840, 07-0142 / 201106342

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, we plan to reduce the amount of radiation treatment received to healthy tissue

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
CTV1 = 66 Gy in 33 fractions CTV2 = 60 Gy in 33 fractions CTV3 = 56 Gy in 33 fractions CTV3 Proto = 56 Gy in 33 fractions
imrt

Primary Outcomes

Measure
Eliminate radiation of PN0 neck(s) and demonstrate >90% control in the unirradiated neck(s)
time frame: 12 months of follow-up

Secondary Outcomes

Measure
Evaluate the rates of locoregional control, disease specific survival, overall survival, and patterns of failure
time frame: 5 years from completion of treatment
Evaluate impact of treatment volume on toxicity and quality of life through the use of validated PRO QOL instruments with PTV as a continuous variable.
time frame: Acute toxicity = through 90 days after completion of treatment, Late = from 90 days through patient's death
Compare standard treatment volume (CTV and PTV) with protocol defined treatment volume in terms of organ specific dose volume histograms
time frame: Completion of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy
Principal investigator Wade Thorstad, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.