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Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment


Phase 2
18 Years
80 Years
Not Enrolling
Both
Brain Neoplasms

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Trial Information

Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rates. Assessed With Cranial MRI

Outcome Description:

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.

Outcome Time Frame:

90 days

Safety Issue:

No

Principal Investigator

Carlos Gamboa-Vignolle, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto Nacional de Cancerología de México

Authority:

Mexico: Federal Commission for Protection Against Health Risks

Study ID:

006/004/TEI

NCT ID:

NCT01015534

Start Date:

January 2006

Completion Date:

October 2009

Related Keywords:

  • Brain Neoplasms
  • Brain metastases
  • Temozolomide
  • Whole-brain radiotherapy
  • Phase II trial
  • Brain Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

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