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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00921739

Acronym

ESIMRT

Enrollment

Registered

2009-06-16

Start date

2009-09-11

Completion date

2016-11-30

Last updated

2020-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

RADIATIONEsophageal 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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (MTD) of IMRT	within 30 days of completing RT

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026