A Phase 2 interventional study of temozolomide and adjuvant therapy in Brain and Central Nervous System Tumors, sponsored by Children's Oncology Group. Completed at 230 sites in 7 countries. Open to participants aged 3 Years to 21 Years. Per ClinicalTrials.gov, last updated 2014-02-21.
Sponsored by Children's Oncology Group · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.
OBJECTIVES:
OUTLINE: This is a multicenter study.
NOTE: *For patients with diffuse intrinsic pontine glioma only
Patients are followed every 3-6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 50-60 patients will be accrued for this study within 12-14 months.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's enrollment of 170 is above the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed CNS tumor of the following types:
High grade glioma (HGG) of one of the following histologies:
Diffuse intrinsic pontine glioma (DIPG)
No tumors with features not typical of diffuse intrinsic brainstem glioma, including any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Drug: temozolomide · Procedure: adjuvant therapy · Radiation: radiation therapy
Improved outcome
Toxicity as assessed by NCI CTCAE v. 2.0
Showing the first 100 of 230 sites across 7 countries.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Children's Oncology Group