Phase II Trial Evaluating Elimination of Radiation Therapy
This trial is active, not recruiting.
|Condition||cancer of the larynx|
|Sponsor||Washington University School of Medicine|
|Start date||April 2007|
|End date||February 2014|
|Trial size||74 participants|
|Trial identifier||NCT00593840, 07-0142 / 201106342|
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
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
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
Eliminate radiation of PN0 neck(s) and demonstrate >90% control in the unirradiated neck(s)
time frame: 12 months of follow-up
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
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.
|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.|
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