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CompletedPhase 1NCT00921739
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEsophageal sparing IMRT

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Duke University

Study sponsor

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.

Cancer type
Non-small cell lung cancer (NSCLC)→Small cell lung cancer (SCLC)→
Treatment approach
Chemotherapy→Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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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