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

Primary Purpose

Non Small Cell Lung Cancer, Small Cell Lung Cancer, Thymoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Esophageal sparing IMRT
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non small cell lung cancer, Small cell lung cancer, Thymoma unresectable, Thymic carcinoma unresectable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT concurrent with chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD) of IMRT

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2009
Last Updated
March 31, 2020
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00921739
Brief Title
Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies
Acronym
ESIMRT
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 11, 2009 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Small Cell Lung Cancer, Thymoma, Thymus Neoplasms
Keywords
Non small cell lung cancer, Small cell lung cancer, Thymoma unresectable, Thymic carcinoma unresectable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMRT concurrent with chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Esophageal sparing IMRT
Intervention Description
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 Measure Information:
Title
Maximum tolerated dose (MTD) of IMRT
Time Frame
within 30 days of completing RT
Secondary Outcome Measure Information:
Title
The occurrence of RT-induced acute esophagitis
Time Frame
One year
Title
To determine if biological predictors of esophagitis can identify patients who develop severe esophageal toxicity during radiation therapy
Description
Blood will be drawn at specific time intervals, plasma will be analysed for Glutathione Oxidation, Citrulline, Lipid peroxidation, DNA oxidation, and Tetrahydrobiopterin.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Kelsey, MD
Organizational Affiliation
Duke University Medical Center, Dept Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11571735
Citation
Socinski MA, Rosenman JG, Halle J, Schell MJ, Lin Y, Russo S, Rivera MP, Clark J, Limentani S, Fraser R, Mitchell W, Detterbeck FC. Dose-escalating conformal thoracic radiation therapy with induction and concurrent carboplatin/paclitaxel in unresectable stage IIIA/B nonsmall cell lung carcinoma: a modified phase I/II trial. Cancer. 2001 Sep 1;92(5):1213-23. doi: 10.1002/1097-0142(20010901)92:53.0.co;2-0.
Results Reference
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PubMed Identifier
16730134
Citation
Schild SE, McGinnis WL, Graham D, Hillman S, Fitch TR, Northfelt D, Garces YI, Shahidi H, Tschetter LK, Schaefer PL, Adjei A, Jett J. Results of a Phase I trial of concurrent chemotherapy and escalating doses of radiation for unresectable non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1106-11. doi: 10.1016/j.ijrobp.2006.02.046. Epub 2006 May 26.
Results Reference
background
PubMed Identifier
12243810
Citation
Schild SE, Stella PJ, Geyer SM, Bonner JA, Marks RS, McGinnis WL, Goetz SP, Kuross SA, Mailliard JA, Kugler JW, Schaefer PL, Jett JR. Phase III trial comparing chemotherapy plus once-daily or twice-daily radiotherapy in Stage III non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):370-8. doi: 10.1016/s0360-3016(02)02930-9.
Results Reference
background
PubMed Identifier
34114913
Citation
Lafata KJ, Corradetti MN, Gao J, Jacobs CD, Weng J, Chang Y, Wang C, Hatch A, Xanthopoulos E, Jones G, Kelsey CR, Yin FF. Radiogenomic Analysis of Locally Advanced Lung Cancer Based on CT Imaging and Intratreatment Changes in Cell-Free DNA. Radiol Imaging Cancer. 2021 Apr;3(4):e200157. doi: 10.1148/rycan.2021200157.
Results Reference
derived

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

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