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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02994264
Other study ID # ICL_2015_0002
Secondary ID
Status Completed
Phase N/A
First received December 13, 2016
Last updated December 14, 2016
Start date August 2015
Est. completion date January 2016

Study information

Verified date December 2016
Source Institut de Cancérologie de Lorraine
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertésFrance: Committee for the Protection of Personnes
Study type Observational

Clinical Trial Summary

The aim of the study is to retrospectively evaluate the outcome of adjuvant concurrent chemoradiation delivered to patients with high grade non-metastatic soft tissue sarcomas of the extremities at the investigators institution paired with patients treated by adjuvant radiation therapy


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients consecutive enrolled from 1990 to 2004 with soft tissue sarcomas located either in the limbs or girdles, superficial or deep, grade 2 or 3 (FNCLCC), who were first treated with radical conservative surgery and adjuvant RT atto a minimum biologically equivalent dose of 45 Gy, with or without concurrent adjuvant chemotherapy.

Exclusion Criteria:

- A patient record captured outside the time frame from 1990 to 2004 with trunk, retro-peritoneum, and head and neck localisations, grade 1 histology and, PS=3, were excluded as well as and those plus patients who had received neoadjuvant treatment. Differentiated liposarcomas, dermatofibrosarcomas protuberans, extraskeletal Ewing's sarcomas, primitive neuroectodermal tumors and osteosarcomas were also excluded due to specific treatment strategies.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Radiation:
adjuvant concurrent chemoradiation


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Institut de Cancérologie de Lorraine

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival 60 months No
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