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UnknownPhase 1NCT01711697
Official study title

An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Study summary

This phase I trial studies the best dose of radiation therapy in treating patients with locally advanced non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy, such as stereotactic body radiation therapy (SBRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. SBRT has been shown to provide excellent results when used in early stage lung cancer, but has not yet been applied to patients with more advanced disease.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedstereotactic body radiation therapy and carboplatin

Plus 2 other study approaches.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 23, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Emory University

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Emory University
Interventions being studied
Radiation: stereotactic body radiation therapy; Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy
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)→
Disease setting
Early-stage or resectable→Locally advanced→
Treatment approach
Chemotherapy→Radiation therapy→Surgery→
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
  • Biopsy proven NSCLC, within 8 weeks prior to patient registration
  • Unresectable disease
  • Clinical stage Tx, T1-T4, N1-3, M0
  • Karnofsky performance status (KPS) ≥ 70
  • Pretreatment positron emission tomography (PET) CT scan to rule out metastatic disease
  • The primary tumor may not be larger than 8 cm in maximum dimension
  • If the primary tumor is central in location, defined as within 2 cm from the tracheobronchial tree, it must be no larger than 5 cm
  • Mediastinal and hilar lymphadenopathy can be no larger than 5 cm at any nodal station
  • Pretreatment brain CT with contrast or brain MRI to rule out metastases
  • Pathologic assessment of the mediastinum to document involved nodal stations
  • All of the above inclusion criteria must occur within 8 weeks prior to patient registration, with the exception of pathologic assessment of the mediastinum and biopsy to confirm NSCLC, which can be done within 12 weeks of patient registration
Reasons someone may not be able to joinExclusion criteria
  • Prior history of lung cancer
  • Pregnancy
  • Prior history of radiation to the chest

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

  • Grady Health SystemAtlanta, Georgia
  • Emory University Hospital MidtownAtlanta, Georgia
  • Emory University Winship Cancer InstituteAtlanta, Georgia
  • Siteman Cancer Center - Washington UniversitySt Louis, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 23, 2021. Always confirm current availability with the study team.

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