NCT02994264

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
Last Updated

December 15, 2016

Status Verified

December 1, 2016

Enrollment Period

5 months

First QC Date

December 13, 2016

Last Update Submit

December 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • overall survival

    60 months

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 15, 2016

Study Start

August 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

December 15, 2016

Record last verified: 2016-12