Trial · NCT01602666
Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
NCT01602666, Phase 2, Completed, Children's Oncology Group; results first posted 2020-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors. Trials, record NCT01602666. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01602666
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
- NCT number
- NCT01602666
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 262 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Central Nervous System Nongerminomatous Germ Cell Tumor, Childhood Germinoma
- Interventions
- 3-Dimensional Conformal Radiation Therapy, Carboplatin, Etoposide, Ifosfamide, Intensity-Modulated Radiation Therapy
- First posted
- 2012-05-21
- Last updated
- 2025-11-20
- Results first posted
- 2020-12-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 3 years | 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. |
| Primary | 3-year PFS Rate of Patients With Localized CNS Germinoma Who Were Treated With Reduced Dose Radiation Therapy | 3 years | 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. |
| Primary | Neurocognitive Function Using the ALTE07C1 Protocol | Up to 5 years | 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. |
| Secondary | Estimation of the PFS Distribution of Patients With NGGCT Treated With Involved-field Radiation Therapy (IFR) | Up to 3 years | 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. |
| Secondary | Estimation of the Overall Survival (OS) Distribution of Patients With NGGCT Treated With IFR Assessed | Up to 3 years | 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. |
| Secondary | 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 | Up to 3 years | 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. |
| Secondary | 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 | Up to 3 years | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 3 years | 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. | percentage of patients | NUMBER |
| PRIMARY | 3-year PFS Rate of Patients With Localized CNS Germinoma Who Were Treated With Reduced Dose Radiation Therapy | 3 years | 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. | percentage of patients | NUMBER |
| PRIMARY | Neurocognitive Function Using the ALTE07C1 Protocol | Up to 5 years | All eligible patients who received the radiation therapy were included as evaluable patients for analysis. | Standardized Scores | MEAN |
| SECONDARY | Estimation of the PFS Distribution of Patients With NGGCT Treated With Involved-field Radiation Therapy (IFR) | Up to 3 years | 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. | percentage of patients | NUMBER |
| SECONDARY | Estimation of the Overall Survival (OS) Distribution of Patients With NGGCT Treated With IFR Assessed | Up to 3 years | 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. | percentage of patients | NUMBER |
| SECONDARY | 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 | Up to 3 years | 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. | percentage of patients | NUMBER |
| SECONDARY | 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 | Up to 3 years | 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 | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 83.33 | 95% Confidence Interval 72.13 to 91.38 | percentage of patients | |
| 3-year PFS Rate of Patients With Localized CNS Germinoma Who Were Treated With Reduced Dose Radiation Therapy | Stratum 2 Localized Germinoma | 86.49 | 95% Confidence Interval 76.55 to 93.32 | percentage of patients | |
| Neurocognitive Function Using the ALTE07C1 Protocol | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | Attention/Concentration at 9 months | 9.4 | 95% Confidence Interval 8.6 to 10.3 | Standardized Scores |
| Neurocognitive Function Using the ALTE07C1 Protocol | Stratum 2 Localized Germinoma | Attention/Concentration at 9 months | 10.0 | 95% Confidence Interval 9.3 to 10.7 | Standardized Scores |
| Neurocognitive Function Using the ALTE07C1 Protocol | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | Attention/Concentration at 30 months | 10.1 | 95% Confidence Interval 9.1 to 11.1 | Standardized Scores |
| Neurocognitive Function Using the ALTE07C1 Protocol | Stratum 2 Localized Germinoma | Attention/Concentration at 30 months | 9.8 | 95% Confidence Interval 9.0 to 10.6 | Standardized Scores |
| Neurocognitive Function Using the ALTE07C1 Protocol | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | Attention/Concentration at 60 months | 9.3 | 95% Confidence Interval 8.3 to 10.4 | Standardized Scores |
| Neurocognitive Function Using the ALTE07C1 Protocol | Stratum 2 Localized Germinoma | Attention/Concentration at 60 months | 10.2 | 95% Confidence Interval 9.1 to 11.3 | Standardized Scores |
| Neurocognitive Function Using the ALTE07C1 Protocol | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | Estimated IQ at 9 months | 94.3 | 95% Confidence Interval 90.0 to 98.7 | Standardized Scores |
| Neurocognitive Function Using the ALTE07C1 Protocol | Stratum 2 Localized Germinoma | Estimated IQ at 9 months | 99.0 | 95% Confidence Interval 95.9 to 102.1 | Standardized Scores |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Chemotherapy | STARTED | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 107 | |
| Induction Chemotherapy | STARTED | Stratum 2 Localized Germinoma | 137 | |
| Induction Chemotherapy | COMPLETED | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 70 | |
| Induction Chemotherapy | COMPLETED | Stratum 2 Localized Germinoma | 113 | |
| Induction Chemotherapy | NOT COMPLETED | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 37 | |
| Induction Chemotherapy | NOT COMPLETED | Stratum 2 Localized Germinoma | 24 | |
| Radiation Therapy on Protocol | STARTED | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 70 | |
| Radiation Therapy on Protocol | STARTED | Stratum 2 Localized Germinoma | 113 | |
| Radiation Therapy on Protocol | Evaluable for Reduced Dose (30Gy) | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 66 | |
| Radiation Therapy on Protocol | Evaluable for Reduced Dose (30Gy) | Stratum 2 Localized Germinoma | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events210
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 2 | 107 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Stratum 2 Localized Germinoma | 2 | 137 | 2 |
| other | Acidosis | Metabolism and nutrition disorders | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 1 | 107 | 1 |
| other | Acidosis | Metabolism and nutrition disorders | Stratum 2 Localized Germinoma | 0 | 137 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 1 | 107 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Stratum 2 Localized Germinoma | 0 | 137 | 0 |
| other | Adrenal insufficiency | Endocrine disorders | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 0 | 107 | 0 |
| other | Adrenal insufficiency | Endocrine disorders | Stratum 2 Localized Germinoma | 1 | 137 | 1 |
| other | Alanine aminotransferase increased | Investigations | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 10 | 107 | 13 |
| other | Alanine aminotransferase increased | Investigations | Stratum 2 Localized Germinoma | 15 | 137 | 23 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 13 | 107 |
| Total, all-cause mortality | Stratum 2 Localized Germinoma | 2 | 137 |
| Total, other adverse events | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 84 | 107 |
| Total, other adverse events | Stratum 2 Localized Germinoma | 107 | 137 |
| Total, serious adverse events | Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 5 | 107 |
| Total, serious adverse events | Stratum 2 Localized Germinoma | 1 | 137 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31545689 | DERIVED |
Source PubMed
Grants3
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| K12CA086913 | Paul Calabresi Award in Clinical Oncology Research | BORGES, VIRGINIA F.; SLANSKY, JILL E | UNIVERSITY OF COLORADO DENVER | NATIONAL CANCER INSTITUTE | 2000 to 2025 | NIH RePORTER |
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) vs Stratum 2 Localized Germinoma: deaths from any cause | Trial comparisons |
| Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) vs Stratum 2 Localized Germinoma: serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Digit Span Test | Primary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01602666
GET https://conductscience.org/api/trials/v1/NCT01602666/results?page=2