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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-11

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer Small Cell Lung Cancer Thymoma Thymus Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Esophageal sparing IMRT

Intervention Type RADIATION

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).

Interventions

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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).

Intervention Type RADIATION

Eligibility Criteria

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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