Phase 2
Completed N=80
Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma
Sarcoma, Soft Tissue
Source: ClinicalTrials.gov NCT00189137 ↗
Enrolled (actual)
80
Serious AEs
30.0%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Patients Hospitalized in Each Arm. — 35; 26 percentage of patients hospitalized
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Hospitalized in Each Arm. |
35; 26 | — |
| SECONDARY The Percentage of Patients Alive Without Disease at 2 Years |
57; 74 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00189137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.