A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide With Radiotherapy in Diffuse Pontine Gliomas
- To evaluate the time to death in patients with newly diagnosed diffuse pontine gliomas,
when treated with the combination of concomitant low-dose oral temozolomide and
radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose
- To assess the quality of life of patients with diffuse pontine gliomas during and after
- To evaluate the time to tumor progression in patients with newly diagnosed diffuse
pontine gliomas, when treated with the combination of concomitant low-dose oral
temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with
extended low-dose temozolomide.
- To evaluate and document toxicities from the administration of temozolomide combined
with radiotherapy and to further study any toxicities associated with the chronic
administration of the extended low-dose temozolomide schedule in this population group.
- To document radiological response to the above treatment with MR imaging and, where
available, functional imaging.
OUTLINE: This is a multicenter study.
- Chemoradiotherapy: Patients receive oral temozolomide once daily for 6 weeks (7 days
per week) with concurrent radiotherapy (5 days per week).
Patients without evidence of disease progression proceed to maintenance therapy beginning at
least 4 weeks after completion of radiotherapy.
- Maintenance therapy: Patients receive oral temozolomide daily on days 1-21. Treatment
repeats every 4 weeks for up to 1 year in the absence of disease progression or
Quality of life is assessed prior to chemoradiotherapy and prior to course 1 of adjuvant
temozolomide and prior to every 3 subsequent courses of adjuvant temozolomide.
After completion of study therapy, patients are followed every 8 weeks.
Allocation: Non-Randomized, Primary Purpose: Treatment
Simon Bailey, MD
Sir James Spence Institute of Child Health at Royal Victoria Infirmary