Trial · NCT00499616
Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma
NCT00499616, Phase 3, Completed, Children's Oncology Group; results first posted 2017-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma. Trials, record NCT00499616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00499616
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma
- NCT number
- NCT00499616
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 464 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Neuroblastoma
- Interventions
- carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, topotecan hydrochloride, Isotretinoin, Surgery, Filgrastim
- First posted
- 2007-07-11
- Last updated
- 2021-07-06
- Results first posted
- 2017-06-27
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) Rates | 3 years | OS time is calculated from date of enrollment until death, or until last contact if the patient is alive. |
| Primary | Definitive Determination of the Prognostic Ability of 1p and 11q | At baseline | Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q. |
| Primary | Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961 | Up to 3 years | Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients \< 1 yrs of age. |
| Primary | Comparison Between Reduce Intensity of Therapy for Patients With Unfavorable Histology Neuroblastoma and Patients Unfavorable Histology Neuroblastoma Treated on COG-A3961 | Up to 3 years | Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients \< 1 yrs of age |
| Primary | Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma | Up to 3 years | Descriptive analyses of the proportion of stage 4S infants that experience a surgical or post-operative event. |
| Primary | Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment | From baseline to up to 10 years | Kaplan-Meier curves and lifetables of Event Free Survival (EFS) and Overall Survival (OS) rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy. |
| Primary | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS) | Up to 10 years | To test the predictive ability of the extent of surgical resection for EFS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection. |
| Primary | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Overall Survival (OS) Rates | Up to 10 years | To test the predictive ability of the extent of surgical resection for OS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection. |
| Primary | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Surgical Complication Rate | Up to 10 years | To test for the association of the extent of surgical resection (CR vs \<CR) with surgical complications rate (complications of any kind vs no complications at all), a chi-square test will be performed. |
| Secondary | Second-event-free Survival (E2FS) | From the time of the first progressive, non-metastatic event until the subsequent occurrence of relapse, progressive disease, secondary malignancy, or death; up to 3 years | E2FS (from time of first event) will be calculated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) Rates | 3 years | Eligible intermediate risk patients. | percentage of participants | NUMBER |
| PRIMARY | Definitive Determination of the Prognostic Ability of 1p and 11q | At baseline | Eligible intermediate risk patients with 1p and 11q data. | percentage of 3 yr EFS/OS rate | NUMBER |
| PRIMARY | Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961 | Up to 3 years | Eligible and evaluable patients with Stage 4 neuroblastoma, 12-18 months of age, and favorable biological features. | percentage of 3 yr EFS rate | NUMBER |
| PRIMARY | Comparison Between Reduce Intensity of Therapy for Patients With Unfavorable Histology Neuroblastoma and Patients Unfavorable Histology Neuroblastoma Treated on COG-A3961 | Up to 3 years | Eligible and evaluable patients with Stage 3 neuroblastoma, 12-18 months of age, MYCN non-amplified, and unfavorable histology. | percentage of 3 yr EFS rate | NUMBER |
| PRIMARY | Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma | Up to 3 years | Eligible and evaluable patients with Stage 4S neuroblastoma that had a biopsy or resection. | Proportion | NUMBER |
| PRIMARY | Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment | From baseline to up to 10 years | Eligible and evaluable patients with Stage 4S neuroblastoma unable to undergo biopsy. | percentage survival | NUMBER |
| PRIMARY | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS) | Up to 10 years | Eligible and evaluable intermediate risk patients with reported surgery | percentage of 3 yr EFS survival | NUMBER |
| PRIMARY | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Overall Survival (OS) Rates | Up to 10 years | Eligible and evaluable intermediate risk patients with reported surgery. | percentage of OS rate | NUMBER |
| PRIMARY | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Surgical Complication Rate | Up to 10 years | Eligible and evaluable intermediate risk patients with reported surgery | Proportion with surgical complications | NUMBER |
| SECONDARY | Second-event-free Survival (E2FS) | From the time of the first progressive, non-metastatic event until the subsequent occurrence of relapse, progressive disease, secondary malignancy, or death; up to 3 years | Eligible patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy | Percentage | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) Rates | Group 2 (Chemotherapy, Surgery) | 99.4 | 95% Confidence Interval 98.3 to 100.0 | percentage of participants | |
| Overall Survival (OS) Rates | Group 3 (Chemotherapy, Surgery) | 93.5 | 95% Confidence Interval 89.4 to 97.7 | percentage of participants | |
| Overall Survival (OS) Rates | Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 88.4 | 95% Confidence Interval 81.5 to 95.3 | percentage of participants | |
| Definitive Determination of the Prognostic Ability of 1p and 11q | Group 2 (Chemotherapy, Surgery) | EFS Eligible & evaluable patients without 1p loss | 87.2 | 95% Confidence Interval 82.0 to 92.4 | percentage of 3 yr EFS/OS rate |
| Definitive Determination of the Prognostic Ability of 1p and 11q | Group 3 (Chemotherapy, Surgery) | EFS Eligible & evaluable patients without 1p loss | 84.6 | 95% Confidence Interval 76.8 to 92.5 | percentage of 3 yr EFS/OS rate |
| Definitive Determination of the Prognostic Ability of 1p and 11q | Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | EFS Eligible & evaluable patients without 1p loss | 65.4 | 95% Confidence Interval 50.0 to 80.8 | percentage of 3 yr EFS/OS rate |
| Definitive Determination of the Prognostic Ability of 1p and 11q | Group 2 (Chemotherapy, Surgery) | OS Eligible & evaluable patients without 1p loss | 99.4 | 95% Confidence Interval 98.3 to 100.0 | percentage of 3 yr EFS/OS rate |
| Definitive Determination of the Prognostic Ability of 1p and 11q | Group 3 (Chemotherapy, Surgery) | OS Eligible & evaluable patients without 1p loss | 92.8 | 95% Confidence Interval 87.2 to 98.4 | percentage of 3 yr EFS/OS rate |
| Definitive Determination of the Prognostic Ability of 1p and 11q | Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | OS Eligible & evaluable patients without 1p loss | 83.7 | 95% Confidence Interval 71.6 to 95.8 | percentage of 3 yr EFS/OS rate |
| Definitive Determination of the Prognostic Ability of 1p and 11q | Group 3 (Chemotherapy, Surgery) | EFS Eligible & evaluable patients with 1p loss | 94.7 | 95% Confidence Interval 84.7 to 100.0 | percentage of 3 yr EFS/OS rate |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 2 (Chemotherapy, Surgery) | 176 | |
| Overall Study | STARTED | Group 3 (Chemotherapy, Surgery) | 142 | |
| Overall Study | STARTED | Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 89 | |
| Overall Study | STARTED | Non-intermediate Risk Enrolled on Intermediate Risk Trial | 57 | |
| Overall Study | COMPLETED | Group 2 (Chemotherapy, Surgery) | 161 | |
| Overall Study | COMPLETED | Group 3 (Chemotherapy, Surgery) | 114 | |
| Overall Study | COMPLETED | Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 53 | |
| Overall Study | COMPLETED | Non-intermediate Risk Enrolled on Intermediate Risk Trial | 0 | |
| Overall Study | NOT COMPLETED | Group 2 (Chemotherapy, Surgery) | 15 | |
| Overall Study | NOT COMPLETED | Group 3 (Chemotherapy, Surgery) | 28 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events608
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 | 13200-Anemia | Blood and lymphatic system disorders | Group 2 (Chemotherapy, Surgery) | 60 | 175 | 94 |
| other | 13200-Anemia | Blood and lymphatic system disorders | Group 3 (Chemotherapy, Surgery) | 64 | 140 | 102 |
| other | 13200-Anemia | Blood and lymphatic system disorders | Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 45 | 89 | 105 |
| other | 13200-Anemia | Blood and lymphatic system disorders | Non-intermediate Risk Enrolled on Intermediate Risk Trial | 14 | 42 | 14 |
| other | 17200-Blood and lymphatic system disorders - Other specify | Blood and lymphatic system disorders | Group 2 (Chemotherapy, Surgery) | 0 | 175 | 0 |
| other | 17200-Blood and lymphatic system disorders - Other specify | Blood and lymphatic system disorders | Group 3 (Chemotherapy, Surgery) | 0 | 140 | 0 |
| other | 17200-Blood and lymphatic system disorders - Other specify | Blood and lymphatic system disorders | Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 2 | 89 | 2 |
| other | 17200-Blood and lymphatic system disorders - Other specify | Blood and lymphatic system disorders | Non-intermediate Risk Enrolled on Intermediate Risk Trial | 1 | 42 | 1 |
| other | 25800-Disseminated intravascular coagulation | Blood and lymphatic system disorders | Group 2 (Chemotherapy, Surgery) | 0 | 175 | 0 |
| other | 25800-Disseminated intravascular coagulation | Blood and lymphatic system disorders | Group 3 (Chemotherapy, Surgery) | 2 | 140 | 2 |
1 to 10 of 608Source ClinicalTrials.gov
See all 608 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 2 (Chemotherapy, Surgery) | ||
| Total, all-cause mortality | Group 3 (Chemotherapy, Surgery) | ||
| Total, all-cause mortality | Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | ||
| Total, all-cause mortality | Non-intermediate Risk Enrolled on Intermediate Risk Trial | ||
| Total, other adverse events | Group 2 (Chemotherapy, Surgery) | 135 | 175 |
| Total, other adverse events | Group 3 (Chemotherapy, Surgery) | 114 | 140 |
| Total, other adverse events | Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 76 | 89 |
| Total, other adverse events | Non-intermediate Risk Enrolled on Intermediate Risk Trial | 23 | 42 |
| Total, serious adverse events | Group 2 (Chemotherapy, Surgery) | 2 | 175 |
| Total, serious adverse events | Group 3 (Chemotherapy, Surgery) | 5 | 140 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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