Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT01015534
Status:
COMPLETED
Last Update Posted:
2013-05-08
First Post:
2009-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment
Sponsor:
Instituto Nacional de Cancerologia de Mexico
Organization:
Study Overview
Official Title:
Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE
* Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High daily dose temozolomide combined with fractionated radiotherapy may make tumor cells more sensible to treatment.
PURPOSE
* This randomized phase II trial, assess in patients with brain metastases from solid tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve the results obtained with WBRT.
* Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High daily dose temozolomide combined with fractionated radiotherapy may make tumor cells more sensible to treatment.
PURPOSE
* This randomized phase II trial, assess in patients with brain metastases from solid tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve the results obtained with WBRT.
Detailed Description:
Primary Outcome Measures
* Objective Response Rates
Secondary Outcome Measures
* Survival Free of Brain Metastases progression
* Overall Survival
* Systemic Side effects
Objectives
Primary
* Compare objective response rates in both arms of treatment
Secondary
* Compare survival free of progression in both arms of treatment
* Compare Overall Survival in both arms of treatment
* Compare side effects
* Objective Response Rates
Secondary Outcome Measures
* Survival Free of Brain Metastases progression
* Overall Survival
* Systemic Side effects
Objectives
Primary
* Compare objective response rates in both arms of treatment
Secondary
* Compare survival free of progression in both arms of treatment
* Compare Overall Survival in both arms of treatment
* Compare side effects
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: