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

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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 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.

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Full 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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Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT00921739

Recruitment Status:

Completed

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT00921739

Recruitment Status:

Completed

Sponsor:


Duke University

How clear is this clinincal trial information?

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