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

Duke University

Status and phase: Completed; Phase 1

Conditions: Thymoma; Small Cell Lung Cancer; Thymus Neoplasms; Non Small Cell Lung Cancer

Treatments: Radiation: Esophageal sparing IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT00921739

Pro00017361

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

IMRT concurrent with chemotherapy

Experimental group

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.

Treatment:

Radiation: Esophageal sparing IMRT