Temozolomide and Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer - Study Results

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Lung Cancer Metastatic Cancer
Interventions:	Drug: Temozolomide Radiation: Radiation therapy

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study Activated on 10/18/2005, terminated on 3/13/2007. Institutes include Mayo Clinic Rochester, Northwestern University, Wisconsin, University of, Stanford University, Lankenau Hospital,Toledo Community Hosp Onc Prog CCOP,Sanford Cancer Ctr-Oncology Clinic,Carle Cancer Center CCOP

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Temozolamide and Radiation	Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).

Description

Temozolamide and Radiation

Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).

Participant Flow: Overall Study

	Temozolamide and Radiation
STARTED	26
Began Protocol Therapy	25
Eligible and Treated	21
COMPLETED	2
NOT COMPLETED	24
Adverse Event	3
Withdrawal by Subject	6
Death	2
Lack of Efficacy	7
other disease	1
Not started protocol therapy	1
Ineligible	4

Baseline Characteristics

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Reporting Groups

	Description
Temozolamide and Radiation	Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).

Description

Temozolamide and Radiation

Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).

Baseline Measures

	Temozolamide and Radiation
Number of Participants [units: participants]	21
Age [units: years] Median ( Full Range )	61 ( 40 to 85 )
Gender [units: participants]
Female	9
Male	12
Region of Enrollment [units: participants]
United States	21

Outcome Measures

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1. Primary:

Number of Patients With Intracranial Response [ Time Frame: assessed every cycle while on treatment, then every 3 months for 2 years ]

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2. Secondary:

1-year Neurologic (Central Nervous System, CNS) Progression Free Rate [ Time Frame: assessed every 3 months for 2 years ]

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3. Secondary:

Time to Non-CNS (Systemic) Progression [ Time Frame: assessed every 3 months for 2 years ]

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4. Secondary:

Overall Survival Time [ Time Frame: assessed every 3 months for 2 years ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
phone: 617-632-3012

No publications provided

Responsible Party:	Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00080938 History of Changes
Other Study ID Numbers:	CDR0000357567, U10CA021115, E1F03
Study First Received:	April 7, 2004
Results First Received:	December 30, 2010
Last Updated:	August 22, 2011
Health Authority:	United States: Federal Government