Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment

Instituto Nacional de Cancerologia de Mexico55 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain Neoplasms

Interventions

TemozolomideDRUG

Whole brain irradiationRADIATION

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 * Serum bilirubins ≤ 1.5 mg/dl, * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ twice the upper normal limit Exclusion Criteria * Pregnant or breast feeding woman * History of allergic reaction to iodinated contrast media * Inability to swallow * Systemic chemotherapy in previous 3 weeks * Oral chemotherapy in previous 2 weeks * Prior surgery, chemotherapy, or radiotherapy for a brain neoplasm * Meningeal carcinomatosis

Locations (1)

Instituto Nacional de Cancerología de México

México, D.F, Mexico

Outcomes

Primary Outcomes

Objective Response Rates. Assessed With Cranial MRI

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.

Time frame: 90 days

Secondary Outcomes

Survival Free of Brain Metastases Progression (PFS of BM)

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.

Time frame: at 90 days

Overall Survival

Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.

Time frame: 1 year

Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.

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.

Time frame: 4 months

Data from ClinicalTrials.gov

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