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Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer

NCT00096265 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2018-03-09

Study results available
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Summary

This randomized phase III trial is studying whole-brain radiation therapy and stereotactic radiosurgery with or without temozolomide or erlotinib to see how well they work compared to whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain metastases secondary to non-small cell lung cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by blocking blood flow to the tumor. It is not yet known whether radiation therapy and stereotactic radiosurgery are more effective with or without temozolomide or erlotinib in treating brain metastases.

Conditions

  • Metastatic Malignant Neoplasm in the Brain
  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage IV Non-Small Cell Lung Cancer AJCC v7

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Patients undergo radiation therapy once daily for approximately 3 weeks

DRUG

Erlotinib Hydrochloride

Given orally

RADIATION

Stereotactic Radiosurgery

Patients undergo surgery after radiation therapy

DRUG

Temozolomide

Given orally

Sponsors & Collaborators

  • Radiation Therapy Oncology Group

    collaborator NETWORK

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Paul Sperduto · Radiation Therapy Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-06
Primary Completion
2011-06-14
Completion
2012-04-01

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00096265 on ClinicalTrials.gov