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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01602666
Registration number
NCT01602666
Ethics application status
Date submitted
18/05/2012
Date registered
21/05/2012
Date last updated
19/04/2024
Titles & IDs
Public title
Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
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Scientific title
Phase 2 Trial of Response-Based Radiation Therapy for Patients With Localized Central Nervous System Germ Cell Tumors (CNS GCT)
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Secondary ID [1]
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NCI-2012-01967
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Secondary ID [2]
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ACNS1123
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Central Nervous System Nongerminomatous Germ Cell Tumor
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Childhood Central Nervous System Germinoma
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Cancer
0
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Testicular
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - 3-Dimensional Conformal Radiation Therapy
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - Ifosfamide
Treatment: Other - Intensity-Modulated Radiation Therapy
Experimental: Treatment (combination chemotherapy, radiation therapy) - See Detailed Description
Treatment: Other: 3-Dimensional Conformal Radiation Therapy
Undergo 3D-CRT
Treatment: Drugs: Carboplatin
Given IV
Treatment: Drugs: Etoposide
Given IV
Treatment: Drugs: Ifosfamide
Given IV
Treatment: Other: Intensity-Modulated Radiation Therapy
Undergo IMRT
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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3-year Progression-free Survival (PFS) Rate of Patients With Nongerminomatous Germ Cell Tumor (NGGCT) Who Were Treated With Reduced Dose Whole Ventricular-field Irradiation
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Assessment method [1]
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Binomial estimate of the 3-year PFS rate defined as "Yes" for patients who were followed up per protocol and were progression free at 3-years, and "No" for those who either experienced a progression or were lost to follow-up/withdrew from the trial within 3 years from enrollment. Progression was determined by MRI using the COG Guidelines for Measurement of Tumor Size (>25% increase in 2D or >40% in 3D of the product of perpendicular diameters of the target lesion) as well as by tumor marker assessments which were mandatory for this study.
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Timepoint [1]
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3 years
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Primary outcome [2]
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3-year PFS Rate of Patients With Localized CNS Germinoma Who Were Treated With Reduced Dose Radiation Therapy
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Assessment method [2]
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Binomial estimate of the 3-year PFS rate defined as "Yes" for patients who were followed up per protocol and were progression free at 3-years, and "No" for those who either experienced a progression or were lost to follow-up/withdrew from the trial within 3 years from initiation of treatment. Progression was determined by MRI using the COG Guidelines for Measurement of Tumor Size (>25% increase in 2D or >40% in 3D of the product of perpendicular diameters of the target lesion) as well as by tumor marker assessments which were mandatory for this study.
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Timepoint [2]
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3 years
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Primary outcome [3]
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Neurocognitive Function Using the ALTE07C1 Protocol
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Assessment method [3]
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Estimated scores for processing speed, attention/concentration, and estimated IQ at 9 months, 30 months and 60 months, separately for children and young adults who are treated with reduced radiation dose and volume of irradiation in Stratum 1 (NGGCT) and with dose-reduced radiation therapy in Stratum 2 (germinoma).
Estimated change over these three timepoints for processing speed, attention/concentration, and estimated IQ, separately for children and young adults who are treated with reduced radiation dose and volume of irradiation in Stratum 1 (NGGCT) and with dose-reduced radiation therapy in Stratum 2 (germinoma).
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Timepoint [3]
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Up to 5 years
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Secondary outcome [1]
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Estimation of the PFS Distribution of Patients With NGGCT Treated With Involved-field Radiation Therapy (IFR)
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Assessment method [1]
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Kaplan Meier estimate of the 3-year PFS is provided. PFS is the time interval measured from enrollment until progression or death from any cause or until last follow-up for those who were event free at the time of analysis. Patients who were lost to follow-up or withdrew consent were censored in this analysis. Progression was determined by MRI using the COG Guidelines for Measurement of Tumor Size (>25% increase in 2D or >40% in 3D of the product of perpendicular diameters of the target lesion) as well as by tumor marker assessments which were mandatory for this study.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Estimation of the Overall Survival (OS) Distribution of Patients With NGGCT Treated With IFR Assessed
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Assessment method [2]
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Kaplan Meier estimate of the 3-year overall survival (OS) is provided. OS is the time interval measured from enrollment until death from any cause or until last follow-up for those who were alive at the time of analysis. Patients who were lost to follow-up or withdrew consent were censored in this analysis.
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Estimation of the PFS Distribution of Patients With Localized Germinoma Patients and Cerebrospinal Fluid (CSF) Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL
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Assessment method [3]
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Kaplan Meier estimate of the 3-year PFS rate is provided. PFS is the time interval measured from initiation of treatment until progression or death from any cause or until last follow-up for those who were event free at the time of analysis. Patients who were lost to follow-up or withdrew consent were censored in this analysis. Progression was determined by MRI using the COG Guidelines for Measurement of Tumor Size (>25% increase in 2D or >40% in 3D of the product of perpendicular diameters of the target lesion) as well as by tumor marker assessments which were mandatory for this study.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Estimation of the OS Distribution of Patients With Localized Germinoma Patients and CSF Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL
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Assessment method [4]
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Kaplan Meier estimate of the 3-year overall survival (OS) is provided for each group. OS is the time interval measured from enrollment until death from any cause or until last follow-up for those who were alive at the time of analysis. Patients who were lost to follow-up or withdrew consent were censored in this analysis.
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Timepoint [4]
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Up to 3 years
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Eligibility
Key inclusion criteria
- Patients must be newly diagnosed with localized primary CNS NGGCT (Stratum 1) or
localized primary CNS germinoma (Stratum 2); germ cell tumors located in the
suprasellar, pineal, bifocal (pineal + suprasellar) and ventricles are eligible;
tumors present in the above mentioned locations and with unifocal parenchymal
extension are eligible
- Stratum 1(NGGCT): Patients must have one of the following criteria:
- Patients with serum and/or CSF hCGbeta > 100 mIU/mL or any elevation of
serum and/or CSF alpha-fetoprotein (AFP) > 10 ng/mL or greater than the
institutional normal are eligible, irrespective of biopsy results
- Patients with any of the following elements on biopsy/resection are
eligible, irrespective of serum and/or CSF hCGbeta and AFP levels:
endodermal sinus tumor (yolk sac), embryonal carcinoma, choriocarcinoma,
malignant/immature teratoma, and mixed GCT with malignant GCT elements
- Stratum 2 (Germinoma): Patients must have both serum and CSF markers obtained
(unless obtaining CSF is medically contraindicated) and must have one of the
following criteria to be eligible:
- Patients with institutional normal AFP (or =< 10 ng/mL if no institutional
normal exists) in both serum and CSF (unless medically contraindicated) AND
hCGbeta 5 to =< 50 mIU/mL in serum and/or CSF (unless medically
contraindicated) (only 1 is required to be elevated) are eligible; no
histologic confirmation required
- Patients with bifocal (pineal + suprasellar) involvement or pineal lesion
with diabetes insipidus (D1) AND hCGbeta =< 100 mIU/mL in serum and/or CSF
AND institutional normal AFP (or =< 10 ng/mL if no institutional normal
exists) in both serum and CSF (unless medically contraindicated) are
eligible; no histologic confirmation required
- Patients with histologically confirmed germinoma or germinoma mixed with
mature teratoma and hCGbeta =< 100 mIU/mL in serum and/or CSF and
institutional normal AFP (or =< 10 ng/mL if no institutional normal exists)
in both serum and CSF (unless medically contraindicated) are eligible
- All patients must have a cranial MRI with and without gadolinium at diagnosis/prior to
enrollment; if surgical resection is performed, patients must have pre-operative and
post-operative cranial MRI with and without gadolinium; the post-operative brain MRI
should be obtained within 72 hours of surgery; if patient has a biopsy only,
post-operative cranial MRI is recommended but not required; all patients must have a
spine MRI with gadolinium obtained at diagnosis/prior to enrollment; Note: if the
spine study is performed for the first time after surgical resection or biopsy, it is
recommended to be obtained with and without gadolinium
- Lumbar CSF must be obtained prior to study enrollment unless medically
contraindicated; if a patient undergoes surgery and lumbar CSF cannot be obtained at
this time, then it should be performed at least 10 days following surgery before study
enrollment; false positive cytology can occur within 10 days of surgery; Note:
patients with positive CSF cytology obtained prior to 10 days after surgery may have
cytology repeated to determine eligibility
- Patients must have CSF tumor markers obtained prior to enrollment unless medically
contraindicated; ventricular CSF obtained at the time of CSF diversion procedure (if
performed) is acceptable for tumor markers but lumbar CSF is preferred; in case CSF
diversion and biopsy/surgery are combined, CSF tumor markers should be collected first
- Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123; patients must
be enrolled within 31 days of definitive diagnostic surgery (day 0) or clinical
diagnosis
- Peripheral absolute neutrophil count (ANC) >= 1,000/uL
- Platelet count >= 100,000/uL (transfusion independent)
- Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)
- Creatinine clearance or radioisotope glomular filtration rate (GFR) >= 70 mL/min/1.73
m^2 OR serum creatinine based on age/gender as follows:
- 0.8 mg/dL (2 to < 6 years of age)
- 1.0 mg/dL (6 to < 10 years of age)
- 1.2 mg/dL (10 to < 13 years of age)
- 1.5 mg/dL (male) and 1.4 mg/dL (female) (13 to < 16 years of age)
- 1.7 mg/dL (male) and 1.4 mg/dL (female) (>= 16 years of age)
- Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5
times ULN
- Patients with seizure disorder may be enrolled if well controlled
- Patients must not be in status, coma, or assisted ventilation prior to study
enrollment
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Minimum age
3
Years
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients with mature teratoma or completely resected immature teratoma with normal
tumor markers are not eligible
- Patients with tumors located outside the ventricles (basal ganglia, thalamus) are not
eligible
- Patients with metastatic disease by cranial or spinal MRI evaluation or CSF cytology
(unless medically contraindicated) are not eligible
- Patients must not have received any prior tumor-directed therapy other than surgical
intervention and corticosteroids
- Female patients who are pregnant are ineligible
- Lactating females are not eligible unless they have agreed not to breastfeed their
infants
- Female patients of childbearing potential are not eligible unless a negative pregnancy
test result has been obtained
- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/06/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
262
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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John Hunter Children's Hospital - Hunter Regional Mail Centre
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Sydney Children's Hospital - Randwick
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The Children's Hospital at Westmead - Westmead
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Royal Children's Hospital-Brisbane - Herston
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Queensland Children's Hospital - South Brisbane
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Women's and Children's Hospital-Adelaide - North Adelaide
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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Recruitment hospital [9]
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Perth Children's Hospital - Perth
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2310 - Hunter Regional Mail Centre
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2031 - Randwick
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2145 - Westmead
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4029 - Herston
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4101 - South Brisbane
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5006 - North Adelaide
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3052 - Parkville
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6008 - Perth
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Recruitment postcode(s) [9]
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6009 - Perth
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Recruitment outside Australia
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Alabama
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San Juan
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This phase II trial studies how well chemotherapy followed by radiation therapy work in
treating younger patients with newly diagnosed central nervous system germ cell tumors that
have not spread to other parts of the brain, spinal canal, or body (localized). Drugs used as
chemotherapy, such as carboplatin, etoposide, and ifosfamide, work in different ways to stop
the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. Radiation therapy uses high-energy x rays to kill tumor cells.
Giving chemotherapy followed by radiation therapy may kill more tumor cells.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01602666
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ute K Bartels
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Address
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Children's Oncology Group
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01602666
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