Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria (ProAcTyon)

Centre Oscar Lambret

Status: Completed

Conditions: Soft Tissue Sarcoma

Study type: Observational

Funder types: Other

Identifiers

NCT01650077

ProAcTyon - 1203

Details and patient eligibility

About

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.

Full description

Patient selection is based on a database of retrospectively within the GSF / GETO.

The tumor assessment must be made by scanner at baseline and post-C2 or C3 and should be available and sent to sponsor.

The comparative reading of the imaging is centralized and made without the knowledge of the local assessment:

• sum of the large diameter for 2 imagery (baseline and 1st evaluation
• tumor density on areas of interest for the 2 imaging (baseline and 1st evaluation
• Rank patients according to two methods (Choi and RECIST): complete response, partial response, stability, progress and non-assessable.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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