Trial · NCT00085098
Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor
NCT00085098, Phase 3, Completed, Children's Oncology Group; results first posted 2013-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor. Trials, record NCT00085098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00085098
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor
- NCT number
- NCT00085098
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 24 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Brain Tumor, Central Nervous System Tumor
- Interventions
- filgrastim, carboplatin, cisplatin, cyclophosphamide, etoposide, radiation therapy
- First posted
- 2004-06-11
- Last updated
- 2018-09-07
- Results first posted
- 2013-11-06
- Limitations and caveats
Study closed early due to slow accrual. Analysis plans were not carried out (lack of statistical precision compromised the ability to draw appropriate conclusions). Reported Primary Outcome Measure data reflects data collection through May 2009.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival | Study enrollment until date of earliest qualifying event (QE), date last known to be QE-free if the patient is followed for less than three years and is QE-free at the time of analysis, or 3 years if the patient is QE-free at 3 years | Data will be summarized as number of patients in the following categories at the time of data cutoff for analyses of 3-year EFS: 1)Experienced a qualifying event (QE) (see below);2)Event-free through 3 years of follow-up;3)Event-free until data cutoff (if less than 3 years of follow-up);4)Withdrew from study;5)Lost to follow-up. QEs: 1)disease progression, defined as increase \>= 40% in tumor volume or \>= 25% in tumor area of target lesions;2)development of new lesions;3)occurrence of a second malignant neoplasm, defined as a malignancy with different histological type from trial-qualifying diagnosis;4)death from any cause. Stat. analyses will be based on time from enrollment to the earliest of: 1)occurrence of any of the QEs;2)withdrawal from study or lost to follow-up;3)completion of three years of follow-up event-free;4)data cutoff for completion of the statistical analyses for the protocol's primary objective. NOTE: Reported data are through May 2009 (see Caveats section). |
| Secondary | Number of Participants With a Response to Regimen B | 5 years from beginning of treatment | To assess the complete response rate to pre-radiotherapy chemotherapy (Reg B only). Response was determined after completing 2-4 cycles of chemotherapy on Reg B. Complete Response (CR) is defined as disappearance of all target lesions. |
| Secondary | Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | From the beginning of treatment, assessed up to 5 years | The analysis of toxicity will focus on estimating the rates of key acute and subacute toxicity occurring during the first induction chemotherapy. The list of toxicities of interest include Anemia or Febrile Neutropenia; Nausea or Vomiting; Infections and Infestations; Neutrophil or White blood count decrease; and Hypokalemia or Hyponatremia |
| Secondary | Quality of Life (QOL) and Neurocognitive Assessment (NP) | 2 years from beginning of treatment | The primary endpoints for QOL and NP assessments will be the global scale value from each of these instruments at the two-year time point. Analyses of subscales (if they exist) and of assessments at other times will be of secondary interest. It is assumed that scale values are standardized to a reference normal population. The scores range from 0 to 100 with higher score reflecting better QoL or neurocognitive assessment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival | Study enrollment until date of earliest qualifying event (QE), date last known to be QE-free if the patient is followed for less than three years and is QE-free at the time of analysis, or 3 years if the patient is QE-free at 3 years | By protocol design, all eligible patients were considered in the evaluation of primary study aim. Two (2) patients were considered ineligible. All other patients (10 enrolled to regimen A and 12 enrolled to regimen B) are included in the evaluation for the primary outcome measure. | participants | NUMBER |
| SECONDARY | Number of Participants With a Response to Regimen B | 5 years from beginning of treatment | Patients who were treated in Regimen B and had at least one response assessment are included in this analysis. One patient in Regimen B withdrew from the pre-Radiotherapy chemotherapy and did not have any response assessment were not included for the response analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | From the beginning of treatment, assessed up to 5 years | Patients who received any pre-radiotherapy chemotherapy in Regimen B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality of Life (QOL) and Neurocognitive Assessment (NP) | 2 years from beginning of treatment | All eligible patients who also successfully completed therapy and were assessed for quality of life and neurocognitive outcome. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival | Regimen A (Radiotherapy Only) | Experienced a qualifying event | 1 | 43 to 98 | participants |
| Event-free Survival | Regimen B (Chemotherapy Plus Radiotherapy) | Experienced a qualifying event | 1 | 54 to 99 | participants |
| Event-free Survival | Regimen A (Radiotherapy Only) | Event-free through 3 years of follow-up | 0 | participants | |
| Event-free Survival | Regimen B (Chemotherapy Plus Radiotherapy) | Event-free through 3 years of follow-up | 0 | participants | |
| Event-free Survival | Regimen A (Radiotherapy Only) | Event-free at data cutoff (if < 3 years follow-up) | 9 | participants | |
| Event-free Survival | Regimen B (Chemotherapy Plus Radiotherapy) | Event-free at data cutoff (if < 3 years follow-up) | 11 | participants | |
| Event-free Survival | Regimen A (Radiotherapy Only) | Withdrew from study prior to 3 years of follow-up | 0 | participants | |
| Event-free Survival | Regimen B (Chemotherapy Plus Radiotherapy) | Withdrew from study prior to 3 years of follow-up | 0 | participants | |
| Event-free Survival | Regimen A (Radiotherapy Only) | Lost to follow-up prior to 3 years of follow-up | 0 | participants | |
| Event-free Survival | Regimen B (Chemotherapy Plus Radiotherapy) | Lost to follow-up prior to 3 years of follow-up | 0 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen A (Radiotherapy Only) | 11 | |
| Overall Study | STARTED | Regimen B (Chemotherapy Plus Radiotherapy) | 13 | |
| Overall Study | COMPLETED | Regimen A (Radiotherapy Only) | 10 | |
| Overall Study | COMPLETED | Regimen B (Chemotherapy Plus Radiotherapy) | 11 | |
| Overall Study | NOT COMPLETED | Regimen A (Radiotherapy Only) | 1 | |
| Overall Study | NOT COMPLETED | Regimen B (Chemotherapy Plus Radiotherapy) | 2 |
Source ClinicalTrials.gov
Adverse events42
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 | Alanine aminotransferase increased | Investigations | Regimen A (Radiotherapy Only) | 0 | 10 | 0 |
| other | Alanine aminotransferase increased | Investigations | Regimen B (Chemotherapy Plus Radiotherapy) | 2 | 12 | 2 |
| other | Anaphylaxis | Immune system disorders | Regimen A (Radiotherapy Only) | 0 | 10 | 0 |
| other | Anaphylaxis | Immune system disorders | Regimen B (Chemotherapy Plus Radiotherapy) | 1 | 12 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Regimen A (Radiotherapy Only) | 0 | 10 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Regimen B (Chemotherapy Plus Radiotherapy) | 2 | 12 | 2 |
| other | Anorexia | Metabolism and nutrition disorders | Regimen A (Radiotherapy Only) | 1 | 10 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Regimen B (Chemotherapy Plus Radiotherapy) | 0 | 12 | 0 |
| other | Dehydration | Metabolism and nutrition disorders | Regimen A (Radiotherapy Only) | 1 | 10 | 1 |
| other | Dehydration | Metabolism and nutrition disorders | Regimen B (Chemotherapy Plus Radiotherapy) | 0 | 12 | 0 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen A (Radiotherapy Only) | ||
| Total, all-cause mortality | Regimen B (Chemotherapy Plus Radiotherapy) | ||
| Total, other adverse events | Regimen A (Radiotherapy Only) | 4 | 10 |
| Total, other adverse events | Regimen B (Chemotherapy Plus Radiotherapy) | 11 | 12 |
| Total, serious adverse events | Regimen A (Radiotherapy Only) | 0 | 10 |
| Total, serious adverse events | Regimen B (Chemotherapy Plus Radiotherapy) | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Regimen A (Radiotherapy Only) vs Regimen B (Chemotherapy Plus Radiotherapy): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT00085098
GET https://conductscience.org/api/trials/v1/NCT00085098/results?page=2