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

Phase 1

Completed

• Conditions: Non Small Cell Lung Cancer; Small Cell Lung Cancer; Thymoma; Thymus Neoplasms
• Interventions: Radiation: Esophageal sparing IMRT

• Registration Number: NCT00921739
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Study Start: 2009-09-11
• Primary Completion: 2014-12
• Study Completion: 2016-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

• Prior thoracic irradiation
• Medical contraindications to thoracic irradiation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMRT concurrent with chemotherapy	Esophageal sparing IMRT	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.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of IMRT	within 30 days of completing RT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States