Phase 3
N=24
Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor
Brain Tumor · Central Nervous System Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00085098 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Event-free Survival — 1; 1; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- filgrastim (Biological); carboplatin (Drug); cisplatin (Drug); cyclophosphamide (Drug); etoposide (Drug); radiation therapy (Radiation)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival |
1; 1; 0; 0; 9; 11 | — |
| SECONDARY Number of Participants With a Response to Regimen B |
8 | — |
| SECONDARY Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 |
2; 2; 2; 7; 3 | — |
| SECONDARY Quality of Life (QOL) and Neurocognitive Assessment (NP) |
98.60; 92.43; 41.00; 42.50; 44.00; 42.00 | — |
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in treating germ cell tumor.
PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well it works compared to chemotherapy and radiation therapy in treating patients with newly diagnosed primary CNS germ cell tumor.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary CNS pure germ cell tumor
- Diagnosed within the past 31 days
- Meets any 1 OR none (i.e., M0 [localized disease]) of the following staging criteria:
- M+ (disseminated disease)
- Leptomeningeal or intraventricular metastases visualized on MRI scans of the brain and spine
- Clumps of tumor cells on lumbar cerebrospinal fluid (CSF) cytology
- Visible tumor studding the walls of the lateral or third ventricles noted during endoscopy or surgery
- Primary tumor arising within the parenchyma of the brain, brainstem, or spinal cord
- Measurable multi-focal tumors arising in both the pineal and suprasellar regions (i.e., multiple midline tumors)
- Infiltrative, intra-axial extension on brain MRI > 1 cm beyond enhancing tumor
- Modified M+ (occult multi-focal disease)
- M0 at diagnosis with a localized pineal region tumor with signs and symptoms of diabetes insipidus without measurable disease in the suprasellar region
- Lumbar CSF assay meeting criteria for the following marker profiles:
- Serum and CSF beta human chorionic gonadotropin (β-HCG) ≤ 50 IU/dL
- Serum alpha fetoprotein (AFP) ≤ 10 IU/L AND ≤ institutional norm
- CSF AFP ≤ 2.0 IU/L AND ≤ institutional norm
PATIENT CHARACTERISTICS:
Age
- 3 to 25
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3 (transfusion independent)
- Hemoglobin > 10.0 g/dL (transfusion allowed)
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 70 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Euthyroid (with or without levothyroxine sodium therapy) as determined by normal T4 ± thyroid-stimulating hormone levels*
- Diabetes insipidus allowed provided patient is relatively stable on desmopressin acetate
- Normal endogenous cortisol function*
- Adequate antidiuretic hormone reserves* NOTE: *Unless receiving replacement therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Concurrent replacement hormones allowed (e.g., corticosteroids, levothyroxine sodium, and desmopressin acetate)
Radiotherapy
- Not specified
Surgery
- Prior surgery for germ cell tumor allowed
Other
- No other prior therapy for germ cell tumor
- Concurrent anticonvulsants allowed
Data sourced from ClinicalTrials.gov (NCT00085098). 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.