Clinical trial · Interventional
Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma
Phase II Evaluation of Ifosfamide Plus Doxorubicin & Filgrastim Versus Gemcitabine Plus Docetaxel & Filgrastim in the Treatment of Localized Poor Prognosis Soft Tissue Sarcoma
NCT00189137CI-TRIAL-00020092completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma, Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ifosfamide and doxorubicin vs gemcitabine and docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- doxorubicin and ifosfamide
- interventionNames
- Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel
- type
- EXPERIMENTAL
- label
- gemcitabine and docetaxel
- interventionNames
- Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel
Primary outcomes (1)
- measure
- Percentage of Patients Hospitalized in Each Arm.
- timeFrame
- 12 weeks
- description
- To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
Inclusion Criteria: * no evidence of metastasis * soft tissue sarcoma * intermediate or high histologic grade * greater than 5 cm * Zubrod performance status 1 or better * age 10 or older Exclusion Criteria: * clear cell, alveolar soft part, Ewing's rhabdosarcoma, undifferentiated small cell or Kaposi's * prior chemotherapy * nephrectomy * active unstable angina pectoris * concurrent therapy
References
Publications (1)
- DERIVEDDavis EJ, Zhao L, Lucas DR, Schuetze SM, Baker LH, Zalupski MM, Thomas D, Chugh R. SPARC expression in patients with high-risk localized soft tissue sarcoma treated on a randomized phase II trial of neo/adjuvant chemotherapy. BMC Cancer. 2016 Aug 20;16:663. doi: 10.1186/s12885-016-2694-2. PMID 27544129