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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer, Small Cell Lung Cancer, Thymoma, Thymus Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) of IMRT

Outcome Time Frame:

within 30 days of completing RT

Safety Issue:

Yes

Principal Investigator

Christopher Kelsey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Medical Center, Dept Radiation Oncology

Authority:

United States: Institutional Review Board

Study ID:

Pro00017361

NCT ID:

NCT00921739

Start Date:

August 2009

Completion Date:

April 2015

Related Keywords:

  • Non Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Thymoma
  • Thymus Neoplasms
  • Non small cell lung cancer
  • Small cell lung cancer
  • Thymoma unresectable
  • Thymic carcinoma unresectable
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Esophageal Diseases
  • Lung Neoplasms
  • Thymoma
  • Thymus Neoplasms
  • Small Cell Lung Carcinoma

Name

Location
Duke University Medical Center Durham, North Carolina  27710