Clinical trial · Observational
Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria
Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria: Retrospective Study of Feasibility
NCT01650077CI-TRIAL-00038595ProAcTyoncompletedClinicalTrials.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)
Non-interventional study consisting of a population of patients who had received for soft tissue sarcoma by at least 2 courses of Yondelis® at a dose of 1.5 mg / m² / 3 weeks after failure or intolerance to doxorubicin / ifosfamide from 2007 to 2011.
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 |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the feasibility of tumor response according to CHOI criteria
- timeFrame
- after 6 weeks of treatment
- description
- percentage of cases with a feasible evaluation according to CHOI
Secondary outcomes (4)
- measure
- To classify patients into two categories (progression or no progression) according to RECIST and to CHOI
- timeFrame
- after 6 weeks of treatment
- description
- percentage of cases with a feasible evaluation according to RECIST
- measure
- To determine percentage of false progression
- timeFrame
- after 6 weeks of treatment
- description
- define as patient progressing according to RECIST and not progressing according to CHOI number of patient in each categories, according to each method of measurement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥ 18 years * locally advanced or metastatic soft tissue sarcoma * treated with Yondelis after failure or intolerance to doxorubicin/ifosfamide * treated between 2007 and 2011 * have had at least 2 cycles of Yondelis * assessment of tumor by CT scan (baseline and after 2 or 3 cycles of Yondelis) Exclusion Criteria: * Gastro Intestinal Stromal Tumor GIST * primitive bone sarcoma
References
Publications (0)
Data not yet available
No reference posted for this study.