TriangleNCT01602666 · STUDY IN CONTEXT
Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
Estimated scores for the cognitive functions of processing speed, attention/concentration, and estimated IQ were assessed using the age-appropriate version of the Wechsler Scales of Intelligence. The range for the Processing Speed Index (PSI) is 45 to 155, with a mean of 100 and a standard deviation of 15. Estimated IQ was estimated using 2 subtests from the Wechsler Scales of Intelligence to derive a standard score with a mean of 100 and standard deviation of 15 with a range of 45 to 158. Scores from the 2 subtests were summed and translated to a standard score using published procedures. Attention/concentration was measured by the Digit Span subtest score from the Wechsler Scales of Intelligence. Subset scores have a range of 1-19, with a mean of 10 and standard deviation of 3. Higher scores on all these measures indicate higher or better cognitive performance, lower scores indicate lower or worse cognitive functioning.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- trial label
- Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0000
- source section id
- NCT01602666-om-0000
- source outcome index
- 0
- endpoint
- 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
- endpoint definition
- 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.
- time origin
- 3 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Localized NGGCT treated with 30.6 Gy WVF RT + 23.4 Gy primary site boost. Patients must have had complete response (CR) or partial response (PR) to induction chemotherapy by MRI and markers; or underwent second-look surgery and were found to have mature teratoma, residual scar or fibrosis and fit the definition of CR/PR after second-look surgery.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0001
- source section id
- NCT01602666-om-0001
- source outcome index
- 1
- endpoint
- 3-year PFS Rate of Patients With Localized CNS Germinoma Who Were Treated With Reduced Dose Radiation Therapy
- endpoint definition
- 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.
- time origin
- 3 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Localized CNS Germinoma treated with dose-reduced RT (18 Gy WVI + 12 Gy primary site boost) and had complete response (CR) after induction chemotherapy by MRI and tumor marker criteria; or underwent second-look surgery and were found to have mature teratoma, residual scar or fibrosis and fit the definition of CR after second-look surgery.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0002
- source section id
- NCT01602666-om-0002
- source outcome index
- 2
- endpoint
- Neurocognitive Function Using the ALTE07C1 Protocol
- endpoint definition
- Estimated scores for the cognitive functions of processing speed, attention/concentration, and estimated IQ were assessed using the age-appropriate version of the Wechsler Scales of Intelligence. The range for the Processing Speed Index (PSI) is 45 to 155, with a mean of 100 and a standard deviation of 15. Estimated IQ was estimated using 2 subtests from the Wechsler Scales of Intelligence to derive a standard score with a mean of 100 and standard deviation of 15 with a range of 45 to 158. Scores from the 2 subtests were summed and translated to a standard score using published procedures. Attention/concentration was measured by the Digit Span subtest score from the Wechsler Scales of Intelligence. Subset scores have a range of 1-19, with a mean of 10 and standard deviation of 3. Higher scores on all these measures indicate higher or better cognitive performance, lower scores indicate lower or worse cognitive functioning.
- time origin
- Up to 5 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who received the radiation therapy were included as evaluable patients for analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0003
- source section id
- NCT01602666-om-0003
- source outcome index
- 3
- endpoint
- Estimation of the PFS Distribution of Patients With NGGCT Treated With Involved-field Radiation Therapy (IFR)
- endpoint definition
- 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.
- time origin
- Up to 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Localized NGGCT treated with 30.6 Gy WVF RT + 23.4 Gy primary site boost. Patients must have had complete response (CR) or partial response (PR) to induction chemotherapy by MRI and markers; or underwent second-look surgery and were found to have mature teratoma, residual scar or fibrosis and fit the definition of CR/PR after second-look surgery.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0004
- source section id
- NCT01602666-om-0004
- source outcome index
- 4
- endpoint
- Estimation of the Overall Survival (OS) Distribution of Patients With NGGCT Treated With IFR Assessed
- endpoint definition
- 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.
- time origin
- Up to 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Localized NGGCT treated with 30.6 Gy WVF RT + 23.4 Gy primary site boost. Patients must have had complete response (CR) or partial response (PR) to induction chemotherapy by MRI and markers; or underwent second-look surgery and were found to have mature teratoma, residual scar or fibrosis and fit the definition of CR/PR after second-look surgery.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0005
- source section id
- NCT01602666-om-0005
- source outcome index
- 5
- endpoint
- 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
- endpoint definition
- 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.
- time origin
- Up to 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The eligible patients with localized germinoma 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)
- regimen
- Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
- analyzed count
- 66
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01602666-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Stratum 2 Localized Germinoma
- regimen
- Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with \> 0.5 cm (suprasellar) or \> 1 cm (pineal) but =\< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks.
- analyzed count
- 74
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01602666-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)
- regimen
- Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
- analyzed count
- 70
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01602666-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Stratum 2 Localized Germinoma
- regimen
- Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with \> 0.5 cm (suprasellar) or \> 1 cm (pineal) but =\< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks.
- analyzed count
- 113
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01602666-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)
- regimen
- Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
- analyzed count
- 66
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01602666-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)
- regimen
- Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
- analyzed count
- 66
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01602666-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0005
- arm key
- OG000
- arm label
- hCGbeta <= 50 mIU/mL
- regimen
- CSF/serum hCGbeta \<= 50 mIU/mL
- analyzed count
- 131
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01602666-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- outcome key
- om-0005
- arm key
- OG001
- arm label
- 50 mIU/mL < hCGbeta <= 100 mIU/mL
- regimen
- 50 mIU/mL \< CSF /serum hCGbeta \<= 100 mIU/mL
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01602666-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- harm key
- EG000
- source section id
- NCT01602666-ae
- event group key
- EG000
- event group label
- Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)
- serious affected
- 5
- serious at risk
- 107
- other affected
- 84
- other at risk
- 107
- frequency threshold
- 0
- collection period
- From initiation of induction of therapy to the date of last follow-up, approximately 3 years. For most subjects the adverse events were observed while on active treatment or shortly thereafter.
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-germ-cell-tumors-pediatric
- nct id
- NCT01602666
- harm key
- EG001
- source section id
- NCT01602666-ae
- event group key
- EG001
- event group label
- Stratum 2 Localized Germinoma
- serious affected
- 1
- serious at risk
- 137
- other affected
- 107
- other at risk
- 137
- frequency threshold
- 0
- collection period
- From initiation of induction of therapy to the date of last follow-up, approximately 3 years. For most subjects the adverse events were observed while on active treatment or shortly thereafter.
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice