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

This study is currently recruiting participants.
Verified November 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00921739
First received: June 15, 2009
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Non Small Cell Lung Cancer
Small Cell Lung Cancer
Thymoma
Thymus Neoplasms
Radiation: Esophageal sparing IMRT
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) of IMRT [ Time Frame: within 30 days of completing RT ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The occurrence of RT-induced acute esophagitis [ Time Frame: One year ] [ Designated as safety issue: No ]
  • To determine if biological predictors of esophagitis can identify patients who develop severe esophageal toxicity during radiation therapy [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Blood will be drawn at specific time intervals, plasma will be analysed for Glutathione Oxidation, Citrulline, Lipid peroxidation, DNA oxidation, and Tetrahydrobiopterin.


Estimated Enrollment: 25
Study Start Date: August 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921739

Contacts
Contact: Christopher Kelsey, MD 919 668-5213
Contact: Joan Cahill 919 668-3726 joan.cahill@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Christopher Kelsey, MD    919-668-5213      
Principal Investigator: Christopher Kelsey, MD         
Sub-Investigator: Shiva Das, PhD         
Sub-Investigator: Frank R Dunphy, MD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Christopher Kelsey, MD Duke University Medical Center, Dept Radiation Oncology
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00921739     History of Changes
Other Study ID Numbers: Pro00017361
Study First Received: June 15, 2009
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Non small cell lung cancer
Small cell lung cancer
Thymoma unresectable
Thymic carcinoma unresectable

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Thymoma
Thymus Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 21, 2014