Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment
Overview
- Phase
- Phase 2
- Intervention
- Temozolomide
- Conditions
- Brain Neoplasms
- Sponsor
- Instituto Nacional de Cancerologia de Mexico
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Objective Response Rates. Assessed With Cranial MRI
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
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
Investigators
Carlos Gamboa Vignolle
Radiation Oncologist
Instituto Nacional de Cancerologia de Mexico
Eligibility Criteria
Inclusion Criteria
- •Karnofsky performance status (KPS) ≥ 50
- •Life expectancy ≥ 12 weeks
- •Histologically confirmed non lymphomatous solid tumors at primary site
- •Brain metastases diagnosed with cranial MRI/CT.
- •Extracranial metastases or primary tumor uncontrolled are allowed
- •Hemoglobin ≥ 10 g/dl
- •Absolute neutrophil count of \> 1500/mm3
- •Platelet count of ≥ 100,000/mm3
- •Blood urea nitrogen (BUN) ≤ 25 mg/dl,
- •Serum creatinin ≤ 1.5 mg/dl
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Temozolomide
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.
Intervention: Whole brain irradiation
Whole brain irradiation
Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks
Intervention: Whole brain irradiation
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Survival Free of Brain Metastases Progression (PFS of BM)(at 90 days)
- Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.(4 months)
- Overall Survival(1 year)