Safety and Tolerability of Low-Dose Temozolomide During Whole Brain Radiation in Patients With Cerebral Metastases From Non-Small-Cell Lung Cancer (Study P04071)(TERMINATED)

This study has been terminated.

( Patient target could not be reached within the planned timeframe. )

Study NCT00266812 Information provided by Schering-Plough

First Received on December 16, 2005. Last Updated on July 29, 2009 History of Changes

Results First Received: July 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Carcinoma, Non-Small-Cell Lung
Interventions:	Drug: Temozolomide and radiotherapy Procedure: Whole brain radiotherapy

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
Chemotherapy With Temozolomide and Radiotherapy	Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
Radiotherapy Alone	2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.

Participant Flow: Overall Study

	Chemotherapy With Temozolomide and Radiotherapy	Radiotherapy Alone
STARTED	22	13
COMPLETED	1	2
NOT COMPLETED	21	11
Disease Progression	9	3
Death	5	4
Adverse Event	3	1
Protocol Violation	0	1
Withdrawal by Subject	0	2
Discontinued before starting study drug	4	0

Baseline Characteristics

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Reporting Groups

	Description
Chemotherapy With Temozolomide and Radiotherapy	Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
Radiotherapy Alone	2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.

Baseline Measures

	Chemotherapy With Temozolomide and Radiotherapy	Radiotherapy Alone	Total
Number of Participants [units: participants]	22	13	35
Age [units: years] Mean ± Standard Deviation	65.12 ± 12.72	63.02 ± 8.76	64.3 ± 11.3
Gender [units: participants]
Female	9	5	14
Male	13	8	21

Outcome Measures

1. Primary:

Number of Participants With Progression-free Survival (6 Month) [ Time Frame: 6 months ]

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2. Secondary:

Overall Survival. The Distributions for Survival Time Will be Estimated With the Kaplan-Meier Method and Compared Using the Log Rank Test. [ Time Frame: Time from randomization to death ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

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: Head, Clinical Trials Registry & results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Gerhard Wildauer, MD - Medical Director, Austria Country Operations, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00266812 History of Changes
Other Study ID Numbers:	P04071
Study First Received:	December 16, 2005
Results First Received:	July 29, 2009
Last Updated:	July 29, 2009
Health Authority:	Austria: Federal Ministry for Health and Women