Trial · NCT00072280
Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma
NCT00072280, Phase 2, Terminated, Children's Oncology Group; results first posted 2013-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma. Trials, record NCT00072280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00072280
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma
- NCT number
- NCT00072280
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Sarcoma
- Interventions
- dactinomycin, cyclophosphamide, etoposide, ifosfamide, vincristine sulfate, Conventional Surgery, MESNA (mercaptoethane sulfonate), Filgrastim
- First posted
- 2003-11-06
- Last updated
- 2014-09-30
- Results first posted
- 2013-11-26
- 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 March 2008.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm | Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years) | Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm | Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years) | By protocol design, only eligible patients were considered in the evaluation for the primary outcome measure. One (1) patient was found ineligible, leaving two (2) for the analysis population. | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm | Chemotherapy Plus Possible Surgery | Failed | 1 | participants | |
| Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm | Chemotherapy Plus Possible Surgery | Failure-free through 5 years of follow-up | 0 | participants | |
| Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm | Chemotherapy Plus Possible Surgery | Failure-free at cutoff (if < 5 years follow-up) | 1 | participants | |
| Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm | Chemotherapy Plus Possible Surgery | Withdrew from study | 0 | participants | |
| Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm | Chemotherapy Plus Possible Surgery | Lost to follow-up | 0 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment | STARTED | Chemotherapy Plus Possible Surgery | 3 | |
| Treatment | STARTED | Surgery Only | 4 | |
| Treatment | COMPLETED | Chemotherapy Plus Possible Surgery | 2 | |
| Treatment | COMPLETED | Surgery Only | 2 | |
| Treatment | NOT COMPLETED | Chemotherapy Plus Possible Surgery | 1 | |
| Treatment | NOT COMPLETED | Surgery Only | 2 | |
| Follow-up | STARTED | Chemotherapy Plus Possible Surgery | 2 | |
| Follow-up | STARTED | Surgery Only | 2 | |
| Follow-up | COMPLETED | Chemotherapy Plus Possible Surgery | 0 | |
| Follow-up | COMPLETED | Surgery Only | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events6
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 | Chemotherapy Plus Possible Surgery | 1 | 2 | |
| other | Anemia | Blood and lymphatic system disorders | Surgery Only | 0 | 2 | |
| other | Infections and infestations - Other, specify | Infections and infestations | Chemotherapy Plus Possible Surgery | 1 | 2 | |
| other | Infections and infestations - Other, specify | Infections and infestations | Surgery Only | 0 | 2 | |
| other | Neutrophil count decreased | Investigations | Chemotherapy Plus Possible Surgery | 1 | 2 | |
| other | Neutrophil count decreased | Investigations | Surgery Only | 0 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy Plus Possible Surgery | ||
| Total, all-cause mortality | Surgery Only | ||
| Total, other adverse events | Chemotherapy Plus Possible Surgery | 1 | 2 |
| Total, other adverse events | Surgery Only | 0 | 2 |
| Total, serious adverse events | Chemotherapy Plus Possible Surgery | 0 | 2 |
| Total, serious adverse events | Surgery Only | 0 | 2 |
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 |
|---|
| Chemotherapy Plus Possible Surgery vs Surgery Only: 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/NCT00072280
GET https://conductscience.org/api/trials/v1/NCT00072280/registered