Clinical trial NCT01015534: Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment
Official title: Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Neoplasms
Keywords: Brain metastases
Temozolomide
Whole-brain radiotherapy
Phase II trial
Lead sponsor: Instituto Nacional de Cancerologia de Mexico
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Objective Response Rates. Assessed With Cranial MRI
timeFrame: 90 days
Secondary outcomes:
measure: Survival Free of Brain Metastases Progression (PFS of BM)
timeFrame: at 90 days
measure: Overall Survival
timeFrame: 1 year
measure: Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.
timeFrame: 4 months
Other outcomes:
Locations:
city: México
country: Mexico
facility: Instituto Nacional de Cancerología de México
state: D.F
Study officials:
affiliation: Instituto Nacional de Cancerología de México
name: Carlos Gamboa-Vignolle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones SF, Greco FA, Gian VG, Miranda FT, Raefsky EL, Hainsworth JD, Willcutt NT, Beschorner AF, Kennerly G, Burris HA 3rd. A Phase I trial of protracted oral fixed-dose temozolomide. Cancer. 2005 Nov 1;104(9):1985-91. doi: 10.1002/cncr.21408.
citation: Antonadou D, Paraskevaidis M, Sarris G, Coliarakis N, Economou I, Karageorgis P, Throuvalas N. Phase II randomized trial of temozolomide and concurrent radiotherapy in patients with brain metastases. J Clin Oncol. 2002 Sep 1;20(17):3644-50. doi: 10.1200/JCO.2002.04.140.
citation: Verger E, Gil M, Yaya R, Vinolas N, Villa S, Pujol T, Quinto L, Graus F. Temozolomide and concomitant whole brain radiotherapy in patients with brain metastases: a phase II randomized trial. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):185-91. doi: 10.1016/j.ijrobp.2004.04.061.
citation: Gamboa-Vignolle C, Ferrari-Carballo T, Arrieta O, Mohar A. Whole-brain irradiation with concomitant daily fixed-dose temozolomide for brain metastases treatment: a randomised phase II trial. Radiother Oncol. 2012 Feb;102(2):187-91. doi: 10.1016/j.radonc.2011.12.004. Epub 2012 Jan 16.