Trial · NCT00618813
Two Regimens of Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Localized Ewing Sarcoma Family of Tumors
NCT00618813, Not applicable, Completed, Children's Oncology Group; results first posted 2014-02-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Two Regimens of Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Localized Ewing Sarcoma Family of Tumors. Trials, record NCT00618813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00618813
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Two Regimens of Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Localized Ewing Sarcoma Family of Tumors
- NCT number
- NCT00618813
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 35 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Ewing Sarcoma of Bone, Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Interventions
- radiation therapy, therapeutic conventional surgery, etoposide, ifosfamide, doxorubicin hydrochloride, cyclophosphamide, vincristine sulfate, topotecan hydrochloride, filgrastim
- First posted
- 2008-02-20
- Last updated
- 2014-09-25
- Results first posted
- 2014-02-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Death | Length of protocol therapy (up to 37 weeks) plus 30 days | Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy |
| Primary | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12 | Enrollment to week 12 | The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. |
| Primary | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22 | Week 13 to week 22 | The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. |
| Primary | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28 | Week 23 to week 28 | The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. |
| Primary | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37 | Week 29 to week 37 | The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. |
| Secondary | Event Free Survival | From enrollment to event or 10 years from enrollment, whichever occurs first | Disease progression, occurrence of a second malignant neoplasm (SMN)or death will be considered an analytic event. In all other cases, the patient will be considered censored at last contact. |
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 | Incidence of Death | Length of protocol therapy (up to 37 weeks) plus 30 days | Any patient who receives at least one cycle of protocol therapy, or who dies as a result of complications of therapy prior to completing one cycle of therapy will be evaluable for this outcome | participants | NUMBER |
| PRIMARY | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12 | Enrollment to week 12 | Any patient who receives at least one cycle of protocol therapy, or who is removed from protocol therapy partly or solely because of a dose-limiting toxicity will be evaluable for this outcome. | participants | NUMBER |
| PRIMARY | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22 | Week 13 to week 22 | One patient was not evaluated for dose-limiting toxicity during weeks 13-22 because patient did not complete that segment of protocol therapy. | participants | NUMBER |
| PRIMARY | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28 | Week 23 to week 28 | One patient was not evaluated for DLT during weeks 23-28 because the patient did not complete that segment of therapy. | participants | NUMBER |
| PRIMARY | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37 | Week 29 to week 37 | Two patients were not evaluated for DLT during weeks 29-37 because those patients did not complete that segment of protocol therapy. | participants | NUMBER |
| SECONDARY | Event Free Survival | From enrollment to event or 10 years from enrollment, whichever occurs first |
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 Death | Treatment (Combination Chemotherapy) | 0 | participants | ||
| Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12 | Treatment (Combination Chemotherapy) | 12 | participants | ||
| Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22 | Treatment (Combination Chemotherapy) | 9 | participants | ||
| Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28 | Treatment (Combination Chemotherapy) | 9 | participants | ||
| Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37 | Treatment (Combination Chemotherapy) | 14 | participants |
Source ClinicalTrials.gov
Participant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Combination Chemotherapy) | 35 | |
| Overall Study | Completed Enrollment - Week 12 Treatment | Treatment (Combination Chemotherapy) | 35 | |
| Overall Study | Completed Week 13 to Week 22 Treatment | Treatment (Combination Chemotherapy) | 34 | |
| Overall Study | Completed Week 23 to Week 28 Therapy | Treatment (Combination Chemotherapy) | 34 | |
| Overall Study | Completed Week 29 to Week 37 Therapy | Treatment (Combination Chemotherapy) | 33 | |
| Overall Study | COMPLETED | Treatment (Combination Chemotherapy) | 31 | |
| Overall Study | NOT COMPLETED | Treatment (Combination Chemotherapy) | 4 |
Source ClinicalTrials.gov
Adverse events58
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 | Abdominal pain | Gastrointestinal disorders | Treatment (Combination Chemotherapy) | 4 | 35 | |
| other | Alanine aminotransferase increased | Investigations | Treatment (Combination Chemotherapy) | 6 | 35 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Combination Chemotherapy) | 25 | 35 | |
| other | Anorectal infection | Infections and infestations | Treatment (Combination Chemotherapy) | 1 | 35 | |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Combination Chemotherapy) | 3 | 35 | |
| other | Anxiety | Psychiatric disorders | Treatment (Combination Chemotherapy) | 1 | 35 | |
| other | Apnea | Respiratory, thoracic and mediastinal disorders | Treatment (Combination Chemotherapy) | 1 | 35 | |
| other | Appendicitis | Infections and infestations | Treatment (Combination Chemotherapy) | 1 | 35 | |
| other | Aspartate aminotransferase increased | Investigations | Treatment (Combination Chemotherapy) | 1 | 35 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Treatment (Combination Chemotherapy) | 1 | 35 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Combination Chemotherapy) | ||
| Total, other adverse events | Treatment (Combination Chemotherapy) | 33 | 35 |
| Total, serious adverse events | Treatment (Combination Chemotherapy) | 2 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
Source 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/NCT00618813
GET https://conductscience.org/api/trials/v1/NCT00618813/events?page=2