This research study is examining the benefit of a novel radiation planning approach on the likelihood of developing severe esophagitis (irritation and inflammation of the esophagus) during the course of radiation therapy with concurrent chemotherapy which is associated with very painful and difficult swallowing.
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has approved radiation with chemotherapy as a treatment option for your disease. Currently, there are no established rules to avoid esophagitis in the treatment of lung cancer with radiation therapy. We have developed an IMRT-based technique, termed CEST, to reduce the radiation dose to the part of the esophagus that is located opposite to the tumor. The reason behind this approach is that a lower radiation dose causes less esophagus inflammation and irritation and, therefore, may preserve the swallowing function of the esophagus better. In our clinical experience, reducing the radiation dose to part of the esophagus in this fashion has shown the potential to dramatically decrease the likelihood of severe esophagitis in many though not all people with lung cancer. We therefore wish to analyze this technique further. There is no firm data to indicate that different chemotherapy regimens given at the same time of radiation therapy result in different rates of esophagitis. The Investigators will, therefore, allow any type of standard-of-care chemotherapy regimen at the discretion of the patient's medical oncologist.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Determine whether CEST decreases rate of severe acute esophagitis
Massachusetts General Hospital
Boston, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Number of Participants With Grade 3 or Higher Acute Esophagitis (CTCAE)
Esophagitis will be measured using the Common Toxicity Criteria for Adverse Effects (CTCAE) v4 scoring scale
Time frame: up to 3 months
Number of Participants With Grade 3 or Higher Acute Esophagitis (RTOG)
Esophagitis will be measured using the historical Radiation Therapy Oncology Group (RTOG) scoring scale
Time frame: Baseline , up to 3 Months
Number of Participants With Adverse Events
Adverse events will be measured using CTCAE v4 scoring scale
Time frame: Baseline, up to 2 Years
Rate of Local and Regional Failure
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. No isolated locoregional tumor failures at a median follow-up of up to 2 years.
Time frame: Median follow-up of up to 2 years
Overall Survival Rate
Follow-up time will be calculated from the date of registration to the date of death or the last follow-up date on which the patient was reported alive. Overall survival rates will be estimated using the Kaplan-Meier method.
Time frame: 2 Years
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