CompletedPhase 3NCT01459497
Official study title

Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer

Study summary

The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III NSCLC, who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRadiation Therapy and Conventional radiation

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 17, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?University of Texas Southwestern Medical Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
University of Texas Southwestern Medical Center
Interventions being studied
Radiation: Radiation Therapy; Radiation: Conventional radiation
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

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
  • All patients must be willing and capable to provide informed consent to participate in the protocol.
  • Patients must have appropriate staging studies identifying them as AJCC stage II or III non small cell lung cancer, (according to AJCC Staging, 6th edition; see appendix III), or recurrent non small cell lung cancer. Histologic confirmation of cancer will be required by biopsy or cytology within 6 months of study entry.
  • Patients must have the potential for benefit from local therapy (at the discretion of the investigator).
  • The patient's Zubrod performance status must be 2 or greater OR patients with Zubrod performance status 0-1 and weight loss \>10% are considered eligible. In addition, patients determined to be medically unfit or refusing combined modality therapy are eligible.
  • Age ≥ 18.
  • Patients must have measurable or evaluable disease.
  • Women of childbearing potential and male participants must agree to use an effective method of contraception.
  • Patients must sign study specific informed consent prior to study entry.
  • Patients must not have plans for concurrent chemoradiation therapy.
  • Patients must complete all required pretreatment evaluations
Reasons someone may not be able to joinExclusion criteria
  • Total (aggregate) gross tumor volume \> 500 cm3 (500 cc's or 0.5 Liters)
  • Prior radiotherapy to the region of the study cancer that would result in direct overlap of radiation therapy fields.
  • Chemotherapy given within one week of study registration.
  • Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.

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

  • Georgetown Cancer Center (Austin Cancer Center)Austin, Texas
  • University of Texas Southwestern Medical CenterDallas, Texas
  • Md Anderson Cancer CenterHouston, Texas
  • Baylor Research Institute Dallas, Baylor IrvingIrving, Texas
  • Texas Oncology - ShermanSherman, Texas
  • Scott & White Memorial TempleTemple, Texas
  • Texas Oncology - TylerTyler, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 17, 2024. Always confirm current availability with the study team.

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