Trial · NCT02786719
High-Risk Neuroblastoma Chemotherapy Without G-CSF
NCT02786719, Not applicable, Completed, Baylor College of Medicine; results first posted 2020-03-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High-Risk Neuroblastoma Chemotherapy Without G-CSF. Trials, record NCT02786719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02786719
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High-Risk Neuroblastoma Chemotherapy Without G-CSF
- NCT number
- NCT02786719
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 13 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Neuroblastoma
- Interventions
- Topotecan, Cyclophosphamide, Cisplatin, Etoposide, Vincristine, Cyclophosphamide, Doxorubicin, Sargramostim
- First posted
- 2016-06-01
- Last updated
- 2020-03-12
- Results first posted
- 2020-03-12
- Limitations and caveats
This study was designed to pilot safely decreasing exposure to G-CSF. To formally test the non-inferiority of not giving G-CSF a much larger sample size would be needed. This study does not conclude that G-CSF prevents infections.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Infection | through study completion, approximately 5 months | Incidence of infections in chemotherapy cycles NOT followed by hematopoietic growth factors |
| Secondary | Delay in Chemotherapy Administration Due to Prolonged Neutrophil Recovery | through study completion, approximately 5 months | incidence of delay in chemotherapy administration due to prolonged neutrophil recovery |
| Secondary | the Response Rate Following Induction Chemotherapy Without Prophylactic Granulocyte Colony Stimulating Factor (G-CSF) | through study completion, approximately 5 months | Response rate in the participants that completed all 6 cycles of induction chemotherapy on study. Response rate as categorize by International neuroblastoma response criteria. * Complete response (CR): No evidence of primary tumor; no evidence of metastases (chest, abdomen, liver, bone, bone marrow, nodes, etc.), and urine catecholamines homovanillic acid (HVA)/ vanillylmandelic acid (VMA) normal. MIBG scan must be negative to qualify for CR. * Very good partial response (VGPR): Greater than 90% reduction in primary tumor; no metastatic tumor (as above except bone); no new bone lesions, all pre-existing lesions improved, HVA/VMA normal * Partial Response (PR): 50-90% reduction of primary tumor; 50% or greater reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by 50% |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Infection | through study completion, approximately 5 months | Includes all patients evaluable for endpoint | infections | NUMBER |
| SECONDARY | Delay in Chemotherapy Administration Due to Prolonged Neutrophil Recovery | through study completion, approximately 5 months | 58 cycles of chemotherapy administered to 12 participants | chemotherapy cycles | NUMBER |
| SECONDARY | the Response Rate Following Induction Chemotherapy Without Prophylactic Granulocyte Colony Stimulating Factor (G-CSF) | through study completion, approximately 5 months | Completed all 6 cycles of induction chemotherapy on study | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Infection | High Risk Neuroblastoma Patients | 6 | infections | ||
| Delay in Chemotherapy Administration Due to Prolonged Neutrophil Recovery | High Risk Neuroblastoma Patients | 9 | chemotherapy cycles | ||
| the Response Rate Following Induction Chemotherapy Without Prophylactic Granulocyte Colony Stimulating Factor (G-CSF) | High Risk Neuroblastoma Patients | Partial response | 2 | Participants | |
| the Response Rate Following Induction Chemotherapy Without Prophylactic Granulocyte Colony Stimulating Factor (G-CSF) | High Risk Neuroblastoma Patients | Very good partial response | 2 | Participants | |
| the Response Rate Following Induction Chemotherapy Without Prophylactic Granulocyte Colony Stimulating Factor (G-CSF) | High Risk Neuroblastoma Patients | Complete Response | 4 | 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 | High Risk Neuroblastoma Patients | 13 | |
| Overall Study | COMPLETED | High Risk Neuroblastoma Patients | 12 | |
| Overall Study | NOT COMPLETED | High Risk Neuroblastoma Patients | 1 |
Source ClinicalTrials.gov
Adverse events17
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 | ALT increased | Hepatobiliary disorders | High Risk Neuroblastoma Patients | 1 | 12 | 1 |
| other | Alk phos increased | Hepatobiliary disorders | High Risk Neuroblastoma Patients | 1 | 12 | 1 |
| other | Anemia | Blood and lymphatic system disorders | High Risk Neuroblastoma Patients | 12 | 12 | 73 |
| other | AST increased | Hepatobiliary disorders | High Risk Neuroblastoma Patients | 1 | 12 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | High Risk Neuroblastoma Patients | 12 | 12 | 100 |
| other | Pain | Musculoskeletal and connective tissue disorders | High Risk Neuroblastoma Patients | 2 | 12 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | High Risk Neuroblastoma Patients | 12 | 12 | 93 |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | High Risk Neuroblastoma Patients | 1 | 12 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | High Risk Neuroblastoma Patients | 1 | 12 | 1 |
| other | Weight loss | General disorders | High Risk Neuroblastoma Patients | 1 | 12 | 1 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Risk Neuroblastoma Patients | 0 | 13 |
| Total, other adverse events | High Risk Neuroblastoma Patients | 12 | 12 |
| Total, serious adverse events | High Risk Neuroblastoma Patients | 11 | 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 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/NCT02786719
GET https://conductscience.org/api/trials/v1/NCT02786719/registered