Phase 2 N=55 Randomized Treatment

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

Brain Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT01015534 ↗

Enrolled (actual)

Serious AEs

43.6%

Results posted

May 2013

Primary outcome: Primary: Objective Response Rates. Assessed With Cranial MRI — 78.6; 48.1 Percentage of participants with OR — p=0.019

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Temozolomide (Drug); Whole brain irradiation (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Instituto Nacional de Cancerologia de Mexico
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rates. Assessed With Cranial MRI	78.6; 48.1	0.019 sig
SECONDARY Survival Free of Brain Metastases Progression (PFS of BM)	88.7; 83.7	.704
SECONDARY Overall Survival	8; 8.1	0.84
SECONDARY Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.	1; 0; 11; 6; 1; 0	—

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.

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
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

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Data sourced from ClinicalTrials.gov (NCT01015534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.