NCT02394548

Phase I Trial Of IMRT Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Lung Cancer

A Phase I Trial Of Intensity-Modulated Radiation Therapy (IMRT) Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Non-Small Cell Lung Cancer (NSCLC) And Limited-Stage Small Cell Lung Cancer (LS-SCLC).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-small Cell Lung Carcinoma
• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
RADIATION	Contralateral Esophageal Sparing Technique (CEST)	Determine whether CEST decreases rate of severe acute esophagitis

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-02-01
• Completion: 2021-03-01
• First posted: 2015-03-20
• Last updated: 2021-12-09
• Results posted: 2020-02-24

Locations

2 sites across 1 country: United States