CompletedPhase 1NCT00921739

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

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.

Checked against the public recordLast updated Apr 2, 2020 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations1
SponsorDuke University
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Duke University
Interventions being studied
Radiation: Esophageal sparing IMRT
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Duke University Medical CenterDurham, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 2, 2020. Always confirm current availability with the study team.

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