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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00921739
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : April 2, 2020
Information provided by (Responsible Party):
Duke University

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 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Small Cell Lung Cancer Thymoma Thymus Neoplasms Radiation: Esophageal sparing IMRT Phase 1

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. 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 11, 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IMRT concurrent with chemotherapy
6 fractions of esophageal sparing IMRT weekly for 5-6 weeks (dependent on dose cohort) concurrent with standard chemotherapy: Cisplatin 50 mg/m2 /d intravenously (IV) on days 1, 8, 29, and 36. Etoposide 50 mg/m2 /d IV on days 1 through 5 and 29 through 33.
Radiation: Esophageal sparing IMRT
6 fractions/week of 2Gy each for 29 fx (58 Gy), 31 fx (62 Gy), 33 fx (66 Gy), 35 fx (70 Gy), or 37 fx (74 Gy).

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of IMRT [ Time Frame: within 30 days of completing RT ]

Secondary Outcome Measures :
  1. The occurrence of RT-induced acute esophagitis [ Time Frame: One year ]
  2. To determine if biological predictors of esophagitis can identify patients who develop severe esophageal toxicity during radiation therapy [ Time Frame: Two years ]
    Blood will be drawn at specific time intervals, plasma will be analysed for Glutathione Oxidation, Citrulline, Lipid peroxidation, DNA oxidation, and Tetrahydrobiopterin.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00921739

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Christopher Kelsey, MD Duke University Medical Center, Dept Radiation Oncology
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Responsible Party: Duke University Identifier: NCT00921739    
Other Study ID Numbers: Pro00017361
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Keywords provided by Duke University:
Non small cell lung cancer
Small cell lung cancer
Thymoma unresectable
Thymic carcinoma unresectable
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Thymus Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Lymphatic Diseases