Status:
COMPLETED
Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies
Lead Sponsor:
Duke University
Conditions:
Non Small Cell Lung Cancer
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 us...
Detailed 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. Intensit...
Eligibility Criteria
Inclusion
- 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
- Prior thoracic irradiation
- Medical contraindications to thoracic irradiation
Key Trial Info
Start Date :
September 11 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00921739
Start Date
September 11 2009
End Date
November 1 2016
Last Update
April 2 2020
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710