TriangleNCT01231906 · STUDY IN CONTEXT
Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Time from study enrollment to death or last patient contact.
Percent of viable tumor in the resected tumor specimen after the patient receives 2 cycles of induction chemotherapy. Patients will be classified into groups according to: (1) good risk - less than 10% viable tumor in the resection specimen; and (2) standard risk - 10% or more viable tumor in the resection specimen. Patients who receive radiation therapy to the primary tumor prior to tumor resection or whose tumor is resected prior to the start of systemic therapy are not evaluable for this outcome measure.
Patients will be classified into two groups according to SUVmax as: (1) study population median or greater; and (2) less than the study population median.
Patients will be classified into two groups according to SUVmax as: (1) study population median or greater; and (2) less than the study population median. Patients who receive radiation therapy to the primary tumor prior to the completion of 2 cycles of induction or who do not receive 2 cycles of induction chemotherapy are not evaluable for this outcome measure.
Patients will be classified into two groups: (1) tumor volume 200 ml or greater and (2) tumor volume less than 200 ml.
Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT01231906
- trial label
- Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT01231906
- outcome key
- om-0001
- source section id
- NCT01231906-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- Time from study enrollment to death or last patient contact.
- time origin
- 5 years after enrollment
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT01231906
- outcome key
- om-0002
- source section id
- NCT01231906-om-0002
- source outcome index
- 2
- endpoint
- Histological Response, in Terms of Event Free Survival After Local Control in Patients Who Received Local Control Therapy
- endpoint definition
- Percent of viable tumor in the resected tumor specimen after the patient receives 2 cycles of induction chemotherapy. Patients will be classified into groups according to: (1) good risk - less than 10% viable tumor in the resection specimen; and (2) standard risk - 10% or more viable tumor in the resection specimen. Patients who receive radiation therapy to the primary tumor prior to tumor resection or whose tumor is resected prior to the start of systemic therapy are not evaluable for this outcome measure.
- time origin
- At the end of INDUCTION THERAPY (84 days)
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT01231906
- outcome key
- om-0003
- source section id
- NCT01231906-om-0003
- source outcome index
- 3
- endpoint
- SUVmax as Determined by Positron Emission Tomography (PET)-Determined Response at Enrollment
- endpoint definition
- Patients will be classified into two groups according to SUVmax as: (1) study population median or greater; and (2) less than the study population median.
- time origin
- At study enrollment
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT01231906
- outcome key
- om-0004
- source section id
- NCT01231906-om-0004
- source outcome index
- 4
- endpoint
- SUVmax as Determined by Positron Emission Tomography (PET)-Determined Response After Induction
- endpoint definition
- Patients will be classified into two groups according to SUVmax as: (1) study population median or greater; and (2) less than the study population median. Patients who receive radiation therapy to the primary tumor prior to the completion of 2 cycles of induction or who do not receive 2 cycles of induction chemotherapy are not evaluable for this outcome measure.
- time origin
- At the end of INDUCTION THERAPY (84 days)
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT01231906
- outcome key
- om-0005
- source section id
- NCT01231906-om-0005
- source outcome index
- 5
- endpoint
- Tumor Volume in Milliliters (ml) at Enrollment
- endpoint definition
- Patients will be classified into two groups: (1) tumor volume 200 ml or greater and (2) tumor volume less than 200 ml.
- time origin
- At study enrollment
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT01231906
- outcome key
- om-0000
- source section id
- NCT01231906-om-0000
- source outcome index
- 0
- endpoint
- Event-Free Survival
- endpoint definition
- Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
- time origin
- 5 years after enrollment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Only eligible patients are considered in the calculation of this outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT01231906
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A (Combination Chemotherapy)
- regimen
- INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.
- analyzed count
- 309
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01231906-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT01231906
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B (Combination Chemotherapy, Topotecan Hydrochloride)
- regimen
- INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.
- analyzed count
- 320
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01231906-om-0000#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT01231906
- harm key
- EG000
- source section id
- NCT01231906-ae
- event group key
- EG000
- event group label
- Arm A (Combination Chemotherapy)
- serious affected
- 8
- serious at risk
- 308
- other affected
- 105
- other at risk
- 308
- frequency threshold
- 0
- collection period
- Up to 6 months post-treatment planned as 252 days; All-Cause Mortality: up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT01231906
- harm key
- EG001
- source section id
- NCT01231906-ae
- event group key
- EG001
- event group label
- Arm B (Combination Chemotherapy, Topotecan Hydrochloride)
- serious affected
- 11
- serious at risk
- 318
- other affected
- 91
- other at risk
- 318
- frequency threshold
- 0
- collection period
- Up to 6 months post-treatment planned as 252 days; All-Cause Mortality: up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice