Trial Information
Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
evaluate feasibility of measuring tumor according to CHOI criteria
Outcome Description:
percentage of cases with a feasible evaluation according to CHOI
Outcome Time Frame:
after 6 weeks of treatment
Safety Issue:
No
Principal Investigator
Nicolas PENEL, MD
Investigator Role:
Study Director
Investigator Affiliation:
Oscar Lambret Center
Authority:
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study ID:
ProAcTyon - 1203
NCT ID:
NCT01650077
Start Date:
September 2012
Completion Date:
September 2013
Related Keywords:
- Soft Tissue Sarcoma
- soft tissue sarcoma
- Yondelis
- intolerance to doxorubicin/ifosfamide
- CHOI criteria
- Sarcoma