This trial is active, not recruiting.

Conditions non small cell lung cancer, small cell lung cancer, thymoma, thymus neoplasms
Treatment esophageal sparing imrt
Phase phase 1
Sponsor Duke University
Start date August 2009
End date December 2014
Trial size 25 participants
Trial identifier NCT00921739, Pro00017361


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
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).

Primary Outcomes

Maximum tolerated dose (MTD) of IMRT
time frame: within 30 days of completing RT

Secondary Outcomes

The occurrence of RT-induced acute esophagitis
time frame: One year
To determine if biological predictors of esophagitis can identify patients who develop severe esophageal toxicity during radiation therapy
time frame: Two years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Christopher Kelsey, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Duke University.