Impact of Locoregional Treatment of Soft Tissue Sarcoma on Status of Patients Aged 70 Years and Over

Study Overview
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Brief Summary
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In order to describe functional impact of surgery in elderly patients treated for lower-limb soft-tissue sarcoma, the investigators set up this project which aims to identify prognostic factors among geriatric and functional assessment.

Detailed Description
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This is a prospective cohort including 100 patients > 70 year-old treated by surgery for lower-limb soft-tissue sarcoma. Data on clinical and geriatric characteristics of the patient as well as functional and quality of life assessment will be collected among patient participation (3 years). Primary endpoint is to describe evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status.

Official Title
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Evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status of Patients Aged 70 Years and Over

Conditions
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Soft Tissue Sarcoma Adult

Intervention / Treatment
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* Procedure: Geriatric assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged more than 70 years, Soft tissue sarcoma histologically proven, Sarcoma of the soft tissues of the lower limbs, Operable disease (first-line treatment or neo-adjuvant therapy), ECOG, Performance Status ≤ 2, Decision of surgery validated in Multidisciplinary Consultation Meeting, Reports of the non-opposition documented in the patient file before any procedure specific to the study, Affiliation to system of Social Security (accordance with article L1121-11 of the Code of Public Health). Exclusion Criteria: Metastatic disease from the onset or relapse Participation in another study involving a similar geriatric assessment. Geographic, familial, social, psychological or psychiatric factors that make the patient incapable of undergoing the study's follow-up and procedures. Persons deprived of liberty or placed under judicial protection

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective cohort<br>Geriatric assessment | Procedure: Geriatric assessment<br>* Geriatric assessment, questionnaire assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical functioning assessment | Quality of life questionnaire QLQ-C30 | Change from baseline until 36 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status assessment (TESS) | Toronto Extremity salvage score (TESS) Scale | Change from baseline until 36 months after surgery | 
| Functional status assessment (MST) | Muskuloskeletal Tumor Society (MST) scale | Change from baseline until 36 months after surgery | 
| Time until deterioration of physical functioning | Quality of life questionnaire QLQ-C30 | Change until 36 months after surgery | 
| Quality of life assessment QLQ-C30 | Quality of life questionnaire QLQ-C30 | Change from baseline until 36 months after surgery | 
| Quality of life assessment QLQ-EDL-14 | Quality of life questionnaire QLQ-EDL-14 | Change from baseline until 36 months after surgery | 
| Geriatric parameters assessment - G8 | G8 (onco-geratic screening score) | baseline | 
| Geriatric parameters assessment - CIRS-G | CIRS-G (Cumulative Illness Rating Scale - Geriatrics) | baseline | 
| Geriatric parameters assessment - MNA | MNA (Mini Nutritional Assessment) | Change from baseline until 36 months after surgery | 
| Geriatric parameters assessment - ADL | ADL (Activities in Daily Living) | Change from baseline until 36 months after surgery | 
| Geriatric parameters assessment - IADL | IADL (Instrumental Activities in Daily Living) | Change from baseline until 36 months after surgery | 
| Geriatric parameters assessment - GDS 15 | GDS 15(Geriatric Depression Scale). | Change from baseline until 36 months after surgery | 
| Geriatric parameters assessment - MMSE | MMSE (Mini Mental Status) | Change from baseline until 36 months after surgery | 
| Pain Assessment | Brief Pain Inventory (BPI) questionnaire | Change from Baseline until 36 months after surgery | 
| Surgical complications | classification Clavien Dindo | Change from Day 0 until 12 months after surgery | 
| OS | Overall Survival | Change from Day 0 until 36 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soft Tissue Sarcoma, Surgery, Functional Impact, Elderly Patient, Geriatrics