Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/13/2019 |
| Start Date: | August 2009 |
| End Date: | November 2016 |
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
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prior thoracic irradiation
- Medical contraindications to thoracic irradiation
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