CompletedPhase 3NCT00048997
Official study title

Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer

Study summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if giving radiation therapy to the head is effective in preventing CNS metastases in patients who have stage III non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head works in preventing CNS metastases in patients who have been previously treated for stage III non-small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRadiation therapy and Observation

The study team can explain what participation involves.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 8, 2018 · 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?14 U.S. locations

Locations may change over time.

Who runs it?Radiation Therapy Oncology Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Radiation Therapy Oncology Group
Interventions being studied
Radiation: Radiation therapy; Other: Observation
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
  • DISEASE CHARACTERISTICS:
  • Diagnosis of stage IIIA or IIIB non-small cell lung cancer
  • Complete response, partial response, or stable disease after definitive locoregional therapy (with surgery and/or radiation therapy, with or without chemotherapy (chemotherapy alone does not constitute definitive therapy))
  • No more than 16 weeks since prior therapy
  • No progressive disease
  • No extracranial distant metastatic disease
  • No suspicion of CNS metastases by MRI or CT scan PATIENT CHARACTERISTICS: Age
  • 18 and over Performance status
  • Not specified Life expectancy
  • Not specified Hematopoietic
  • Not specified Hepatic
  • Not specified Renal
  • Not specified Other
  • No other malignancy within the past 3 years except nonmelanoma skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy
  • No concurrent anticancer biologic therapy Chemotherapy
  • See Disease Characteristics
  • No concurrent anticancer cytotoxic chemotherapy Endocrine therapy
  • Not specified Radiotherapy
  • See Disease Characteristics
  • No prior cranial irradiation Surgery
  • See Disease Characteristics Other
  • Recovered from all prior therapies
  • No concurrent enrollment on any other phase III study that has progression-free, disease-free, or overall survival as an endpoint

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

  • Arizona Oncology Services FoundationPhoenix, Arizona
  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - OsbornScottsdale, Arizona
  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - SheaScottsdale, Arizona
  • Resurrection Medical CenterChicago, Illinois
  • Central Maine Comprehensive Cancer Center at Central Maine Medical CenterLewiston, Maine
  • Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine
  • Shore Regional Cancer Center at Memorial Hospital - EastonEaston, Maryland
  • MetroWest Medical Center - Framingham Union HospitalFramingham, Massachusetts
  • Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan
  • Cancer Institute of New Jersey at Cooper University Hospital - CamdenCamden, New Jersey
  • Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania
  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 8, 2018. Always confirm current availability with the study team.

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