A Study to Compare Adjuvant Concurrent Chemoradiation (CCRT) to Adjuvant Radiation Therapy (RT) in Grade 2 and 3 Extremity Soft Tissue Sarcomas

December 14, 2016 updated by: Institut de Cancérologie de Lorraine

A Retrospective Cohort Study to Assess Adjuvant Concurrent Chemoradiation (CCRT) Compared to Adjuvant Radiation Therapy (RT) in the Treatment of Grade 2 and 3 Extremity Soft Tissue Sarcomas

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

Study Overview

Status

Completed

Conditions

Sarcoma,Soft Tissue

Intervention / Treatment

Radiation: adjuvant concurrent chemoradiation

Study Type

Observational

Enrollment (Actual)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival Time Frame: 60 months	60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 15, 2016

Study Record Updates

Last Update Posted (Estimate)