Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies
This trial is active, not recruiting.
|Conditions||non small cell lung cancer, small cell lung cancer, thymoma, thymus neoplasms|
|Treatment||esophageal sparing imrt|
|Start date||August 2009|
|End date||December 2014|
|Trial size||25 participants|
|Trial identifier||NCT00921739, Pro00017361|
Hypothesis 1- Using IMRT, the radiation therapy (RT) dose can be safely escalated from 58 Gy to 74 Gy given as 6 fractions/week with concurrent chemotherapy.
Hypothesis 2- Esophageal motion can be used to customize planning organ at risk volumes.
Hypothesis 3- Biological predictors of acute esophagitis can be used to identify patients at high risk of developing esophageal toxicity from radiation therapy and chemotherapy.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Maximum tolerated dose (MTD) of IMRT
time frame: within 30 days of completing RT
The occurrence of RT-induced acute esophagitis
time frame: One year
To determine if biological predictors of esophagitis can identify patients who develop severe esophageal toxicity during radiation therapy
time frame: Two years
Male or female participants at least 18 years old.
- Histologic documentation of one of the following thoracic malignancies:
- Non-small cell lung cancer (stage III or X (recurrent) with disease confined to local/regional sites)
- Small cell lung cancer (stage II-III)
- Thymoma (unresectable)
- Thymic carcinoma (unresectable)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Weight loss < 10% in preceding 3 months prior to diagnosis
- ANC > or = 1500 and platelet count > or = 100,000.
- Creatinine clearance greater than 50 ml/min
- 18 years of age or older.
- Negative pregnancy test in women of child-bearing potential
- Prior thoracic irradiation
- Medical contraindications to thoracic irradiation
|Official title||Phase I Dose Escalation Study of Accelerated Fractionation With Esophageal Sparing Using Intensity-Modulated Radiation Therapy for Locally-Advanced Thoracic Malignancies Including a Prospective Assessment of Esophageal Motion and Radiation-Induced Esophageal Injury|
|Principal investigator||Christopher Kelsey, MD|
|Description||Prospective phase I study designed to determine the maximum tolerated dose of radiation therapy given in an accelerated fashion (2 Gy/fraction, 6 fractions/week) with concurrent chemotherapy. Intensity-modulated radiation therapy (IMRT) will be utilized to spare the esophagus. All patients on the dose escalation study will participate in additional assessments evaluating esophageal motion and esophageal toxicity from radiation therapy.|
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