Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies

Completed · Phase 1

Conditions studied: Non Small Cell Lung Cancer, Small Cell Lung Cancer, Thymoma, Thymus Neoplasms

In brief

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.

Key facts

Study ID

NCT00921739

Run by

Duke University

People needed

24

Starts

2009-09-11

Expected to finish

2016-11-01

Last updated by the study team

2020-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior thoracic irradiation
• Medical contraindications to thoracic irradiation

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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