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TerminatedNot applicableNCT01992068
Official study title

Pilot Study: Utilizing Manometry to Assess Radiation-Induced Changes in Esophageal Function

Study summary

The purpose of this study is to prospectively assess the feasibility of high-resolution manometry to identify radiation-induced changes in esophageal motility and contractility or "function" in patients undergoing radiation therapy for the treatment of locally advanced lung cancer.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forLocally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 6, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?UNC Lineberger Comprehensive Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
UNC Lineberger Comprehensive Cancer Center
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

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

Disease setting
Locally advanced→
Treatment approach
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
  • Age ≥ 18 years or older
  • Absence of any severe disorders of esophageal motility (patients with reflux and/or a hiatal hernia are eligible)
  • Histologically confirmed lung cancer scheduled to undergo conventionally fractionated radiation treatment
  • Patients that will be treated with a minimum of 45 Gy of radiation therapy
  • Patients with mediastinal nodal disease, or primary lesions that are near the esophagus are eligible provided that they are not having esophageal symptoms believed to be due to the tumor.
Reasons someone may not be able to joinExclusion criteria
  • History of esophageal motility disorder that pre-dates and is unrelated to the present diagnosis of lung cancer
  • History of any prior radiotherapy to the esophagus
  • Pregnant or lactating women
  • Inability to understand and follow swallowing instructions for the esophageal manometry procedure; this is to ensure patient compliance of performing the breath hold technique throughout the radiation therapy treatment
  • Patients with mediastinal nodal disease, or primary lesions, that are having esophageal symptoms believed to be due to the tumor

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

  • Department of Radiation Oncology ClinicChapel Hill, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 6, 2017. Always confirm current availability with the study team.

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