Trial · NCT00047320
Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
NCT00047320, Phase 2, Completed, Children's Oncology Group; results first posted 2014-02-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors. Trials, record NCT00047320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00047320
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
- NCT number
- NCT00047320
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 104 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Brain Tumor, Central Nervous System Tumors, Childhood Germ Cell Tumor
- Interventions
- carboplatin, etoposide, ifosfamide, thiotepa, adjuvant therapy, conventional surgery, neoadjuvant therapy, peripheral blood stem cell transplantation, radiation therapy
- First posted
- 2003-01-27
- Last updated
- 2018-02-14
- Results first posted
- 2014-02-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response to Induction Chemotherapy | 18 weeks | A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response. |
| Secondary | The Probability of Event-free Survival (EFS) | At 3 years from study entry | Event-free Survival was defined as time from study entry to death from any cause, disease progression or recurrence, or second malignant neoplasm. Event-free survival was estimated by KM estimate. |
| Secondary | Progression-free Survival (PFS) | At 3 years from study entry | Progression-free Survival was defined as time from study entry to disease progression or recurrence. Deaths that are clearly unrelated to disease progression, and second neoplasms are censored in this analysis. Progression -free survival was estimated by KM estimate. |
| Secondary | Overall Survival (OS) | At 3 years from study entry | Overall Survival was defined as time from study entry to death from any cause. Overall survival was estimated by KM estimate. |
| Secondary | Number of Patients Experiencing Toxic Death | During chemotherapy (up to 18 weeks) | Toxic death, defined as death predominantly attributable to treatment-related causes. |
| Secondary | Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity | During chemotherapy(up to 18 weeks) | The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response to Induction Chemotherapy | 18 weeks | Of the 102 eligible patients, 85 completed induction chemotherapy with sufficient data to assess response. Central review response assessment is used. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Probability of Event-free Survival (EFS) | At 3 years from study entry | Two ineligible patients were excluded. A total of 102 eligible patients were analyzed. | Probability | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | At 3 years from study entry | Two ineligible patients were excluded. A total of 102 eligible patients were analyzed. one patient died without the disease progression reported. But the death was due to the disease. The death was counted as event when progression-free survival (PFS) was calculated. So EFS and PFS at 3 years were same. | Probability | NUMBER |
| SECONDARY | Overall Survival (OS) | At 3 years from study entry | Two ineligible patients were excluded. A total of 102 eligible patients were analyzed. | Probability | NUMBER |
| SECONDARY | Number of Patients Experiencing Toxic Death | During chemotherapy (up to 18 weeks) | A total of 102 eligible patients treated with induction chemotherapy were included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity | During chemotherapy(up to 18 weeks) | A total of 102 eligible patients treated with induction chemotherapy were included. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response to Induction Chemotherapy | Radiation Therapy (CR From Induction) | Responder | 74 | Participants | |
| Response to Induction Chemotherapy | Radiation Therapy (CR From Induction) | Non-Responder | 11 | Participants | |
| The Probability of Event-free Survival (EFS) | Radiation Therapy (CR From Induction) | 0.837 | 95% Confidence Interval 0.763 to 0.910 | Probability | |
| Progression-free Survival (PFS) | Radiation Therapy (CR From Induction) | 0.837 | 95% Confidence Interval 0.763 to 0.910 | Probability | |
| Overall Survival (OS) | Radiation Therapy (CR From Induction) | 0.927 | 95% Confidence Interval 0.876 to 0.979 | Probability | |
| Number of Patients Experiencing Toxic Death | Radiation Therapy (CR From Induction) | 0 | Participants | ||
| Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity | Radiation Therapy (CR From Induction) | 22 | 95% Confidence Interval 14 to 31 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Radiation Therapy (CR From Induction) | 104 | |
| Overall Study | COMPLETED | Radiation Therapy (CR From Induction) | 76 | |
| Overall Study | NOT COMPLETED | Radiation Therapy (CR From Induction) | 28 |
Source ClinicalTrials.gov
Adverse events34
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 | Anemia | Blood and lymphatic system disorders | Radiation Therapy (CR From Induction) | 51 | 102 | 108 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Radiation Therapy (CR From Induction) | 8 | 102 | 9 |
| other | Nausea | Gastrointestinal disorders | Radiation Therapy (CR From Induction) | 8 | 102 | 16 |
| other | Vomiting | Gastrointestinal disorders | Radiation Therapy (CR From Induction) | 15 | 102 | 28 |
| other | Infections and infestations - Other, specify | Infections and infestations | Radiation Therapy (CR From Induction) | 8 | 102 | 10 |
| other | Alanine aminotransferase increased | Investigations | Radiation Therapy (CR From Induction) | 23 | 102 | 39 |
| other | Aspartate aminotransferase increased | Investigations | Radiation Therapy (CR From Induction) | 15 | 102 | 22 |
| other | Lymphocyte count decreased | Investigations | Radiation Therapy (CR From Induction) | 19 | 102 | 42 |
| other | Neutrophil count decreased | Investigations | Radiation Therapy (CR From Induction) | 53 | 102 | 104 |
| other | Platelet count decreased | Investigations | Radiation Therapy (CR From Induction) | 53 | 102 | 96 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Radiation Therapy (CR From Induction) | ||
| Total, other adverse events | Radiation Therapy (CR From Induction) | 70 | 102 |
| Total, serious adverse events | Radiation Therapy (CR From Induction) | 8 | 102 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31545689 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00047320
GET https://conductscience.org/api/trials/v1/NCT00047320/events?page=2