Phase I Trial Of IMRT Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advance⦠(NCT02394548) | Clinical Trial Compass
CompletedNot Applicable
Phase I Trial Of IMRT Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Lung Cancer
United States27 participantsStarted 2015-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Participants must meet the following criteria on screening examination to be eligible to participate in the study.
* Histologically or cytologically proven diagnosis of NSCLC or SCLC
* NSCLC, patients with clinical stage IIB-IV patients (AJCC, 7th ed.) are eligible, and for SCLC, limited-stage patients are eligible, if documented to be a candidate for definitive radiation and concurrent chemotherapy in the radiation oncologist or medical oncologist clinic note.
* Stage IV NSCLC patients are eligible only if they have a solitary brain metastasis
* Patients with non-malignant pleural effusion are eligible. --- If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:
* When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
* Exudative pleural effusions are excluded, regardless of cytology;
* Effusions that are minimal (ie, not visible on chest x-ray) that are too small to safely tap are eligible.
* Gross tumor (primary tumor or involved lymph node) must be within 1 cm of esophagus on the most recent chest CT scan.
* ECOG performance status 0-1 within 30 days prior to registration;
* Age ā„18
* Women of childbearing potential must indicate that there is not a possibility of being pregnant at the time of enrollment or have a negative serum pregnancy test prior to the initiation of radiation tā¦
What they're measuring
1
Number of Participants With Grade 3 or Higher Acute Esophagitis (CTCAE)