Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment
- 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.
- 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.
|Brain Neoplasms||Drug: Temozolomide Radiation: Whole brain irradiation||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment|
- Objective Response Rates. Assessed With Cranial MRI [ Time Frame: 90 days ]
Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI.
Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants.
- Survival Free of Brain Metastases Progression (PFS of BM) [ Time Frame: at 90 days ]Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms. The progressive brain metastases (PBM) were evaluated with cranial MRI. The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases.
- Overall Survival [ Time Frame: 1 year ]Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.
- Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment. [ Time Frame: 4 months ]
AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0
Grade 3 Severe AE.
Grade 4 Life-threatening or disabling AE.
|Study Start Date:||January 2006|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: Whole brain irradiation plus Temozolomide
Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
Other Names:Radiation: Whole brain irradiation
Other Name: Whole brain radiotherapy
Active Comparator: Whole brain irradiation
Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks
Radiation: Whole brain irradiation
Other Name: Whole brain radiotherapy
Primary Outcome Measures
- Objective Response Rates
Secondary Outcome Measures
- Survival Free of Brain Metastases progression
- Overall Survival
- Systemic Side effects
- Compare objective response rates in both arms of treatment
- Compare survival free of progression in both arms of treatment
- Compare Overall Survival in both arms of treatment
- Compare side effects
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015534
|Instituto Nacional de Cancerología de México|
|México, D.F, Mexico, 14080|
|Principal Investigator:||Carlos Gamboa-Vignolle, MD||Instituto Nacional de Cancerología de México|