Clinical trial · Interventional
Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment
Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment
NCT01015534CI-TRIAL-00010236completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
| Whole brain irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Whole brain irradiation plus Temozolomide
- description
- 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.
- interventionNames
- Drug: Temozolomide
- Radiation: Whole brain irradiation
- type
- ACTIVE_COMPARATOR
- label
- Whole brain irradiation
- description
- Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks
- interventionNames
- Radiation: Whole brain irradiation
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDJones 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. PMID 16134182
- BACKGROUNDAntonadou 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. PMID 12202665
- BACKGROUNDVerger 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. PMID 15629610
- DERIVEDGamboa-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. PMID 22257825