Trial · NCT00134030
Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma
NCT00134030, Phase 3, Completed, Children's Oncology Group; results first posted 2023-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma. Trials, record NCT00134030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00134030
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma
- NCT number
- NCT00134030
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,334 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Localized Osteosarcoma, Metastatic Osteosarcoma
- Interventions
- Cisplatin, Doxorubicin Hydrochloride, Etoposide, Ifosfamide, Methotrexate, Peginterferon Alfa-2b, Quality-of-Life Assessment, Questionnaire Administration, Therapeutic Conventional Surgery
- First posted
- 2005-08-24
- Last updated
- 2023-06-07
- Other registries' IDs
- eudract:2004-000242-20, isrctn:ISRCTN67613327
- Results first posted
- 2023-06-07
- Limitations and caveats
In the good response patients (randomised to MAP-GR or MAPifn), 128 of 357 MAPifn patients completed the planned protocol treatment. Among poor response patients (randomised to MAP-PR or MAPie), 42% of registered patients were not randomised. Further patients were registered to the trial and joined a treatment cohort for follow-up but declined to join the randomisation or were not eligible. The data for these non-randomised patients are not presented here.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) | From date of randomization to date of the event. | EFS is defined as time from randomisation to the first of: death, detection of local recurrence or metastasis, progression of metastatic disease, or detection of a secondary malignancy. EFS will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals. Follow up per participant will be assessed for up to 10 years. The 3 year EFS is provided as a summary. |
| Secondary | Percentage of Patients With Overall Survival | From date of randomization to date of death. | Overall survival is time from randomization until death from any cause. Will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals. Participants will be assessed for up to 10 years. 5 year overall survival is provided as a summary. |
| Secondary | Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | Adverse events are assessed for up to 10 years per participant. | Percentages of patients experiencing grade 3 and 4 adverse events. These will be compared using chi-square tests or Fisher's exact tests where appropriate. |
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 | Event-free Survival (EFS) | From date of randomization to date of the event. | Percentage EFS | NUMBER | |
| SECONDARY | Percentage of Patients With Overall Survival | From date of randomization to date of death. | Percentage of participants | NUMBER | |
| SECONDARY | Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | Adverse events are assessed for up to 10 years per participant. | Adverse events are only analyzed in participants who started treatment and for whom toxicity data were provided. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival (EFS) | MAP-GR | 74 | 95% Confidence Interval 69 to 79 | Percentage EFS | |
| Event-free Survival (EFS) | MAPifn | 77 | 95% Confidence Interval 72 to 81 | Percentage EFS | |
| Event-free Survival (EFS) | MAP-PR | 55 | 95% Confidence Interval 49 to 60 | Percentage EFS | |
| Event-free Survival (EFS) | MAPIE | 53 | 95% Confidence Interval 47 to 59 | Percentage EFS | |
| Percentage of Patients With Overall Survival | MAP-GR | 84 | 95% Confidence Interval 80 to 88 | Percentage of participants | |
| Percentage of Patients With Overall Survival | MAPifn | 84 | 95% Confidence Interval 81 to 88 | Percentage of participants | |
| Percentage of Patients With Overall Survival | MAP-PR | 68 | 95% Confidence Interval 63 to 73 | Percentage of participants | |
| Percentage of Patients With Overall Survival | MAPIE | 68 | 95% Confidence Interval 63 to 73 | Percentage of participants | |
| Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | MAP-GR | 348 | Participants | ||
| Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | MAPifn | 340 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MAP-GR | 359 | |
| Overall Study | STARTED | MAPifn | 357 | |
| Overall Study | STARTED | MAP-PR | 310 | |
| Overall Study | STARTED | MAPIE | 308 | |
| Overall Study | COMPLETED | MAP-GR | 359 | |
| Overall Study | COMPLETED | MAPifn | 357 | |
| Overall Study | COMPLETED | MAP-PR | 310 | |
| Overall Study | COMPLETED | MAPIE | 308 | |
| Overall Study | NOT COMPLETED | MAP-GR | 0 | |
| Overall Study | NOT COMPLETED | MAPifn | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events616
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 |
|---|---|---|---|---|---|---|
| serious | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MAP-GR | 7 | 359 | 11 |
| serious | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MAPifn | 5 | 357 | 6 |
| serious | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MAP-PR | 3 | 310 | 4 |
| serious | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MAPIE | 10 | 308 | 17 |
| serious | NEUTROPENIA | Blood and lymphatic system disorders | MAP-GR | 1 | 359 | 1 |
| serious | NEUTROPENIA | Blood and lymphatic system disorders | MAPifn | 0 | 357 | 0 |
| serious | NEUTROPENIA | Blood and lymphatic system disorders | MAP-PR | 0 | 310 | 0 |
| serious | NEUTROPENIA | Blood and lymphatic system disorders | MAPIE | 0 | 308 | 0 |
| serious | THROMBOCYTOPENIA | Blood and lymphatic system disorders | MAP-GR | 1 | 359 | 1 |
| serious | THROMBOCYTOPENIA | Blood and lymphatic system disorders | MAPifn | 1 | 357 | 1 |
1 to 10 of 616Source ClinicalTrials.gov
See all 616 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MAP-GR | ||
| Total, all-cause mortality | MAPifn | ||
| Total, all-cause mortality | MAP-PR | ||
| Total, all-cause mortality | MAPIE | ||
| Total, other adverse events | MAP-GR | 0 | 359 |
| Total, other adverse events | MAPifn | 0 | 357 |
| Total, other adverse events | MAP-PR | 0 | 310 |
| Total, other adverse events | MAPIE | 0 | 308 |
| Total, serious adverse events | MAP-GR | 49 | 359 |
| Total, serious adverse events | MAPifn | 76 | 357 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 |
| 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 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/NCT00134030
GET https://conductscience.org/api/trials/v1/NCT00134030/events?page=2