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

Overview

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.

Full Title of Study: “Evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status of Patients Aged 70 Years and Over”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 15, 2022

Detailed Description

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.

Interventions

  • Procedure: Geriatric assessment
    • Geriatric assessment, questionnaire assessment

Arms, Groups and Cohorts

  • Experimental: Prospective cohort
    • Geriatric assessment

Clinical Trial Outcome Measures

Primary Measures

  • Change in Physical functioning assessment
    • Time Frame: Change from baseline until 36 months after surgery
    • Quality of life questionnaire QLQ-C30

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Aged more than 70 years, 2. Soft tissue sarcoma histologically proven, 3. Sarcoma of the soft tissues of the lower limbs, 4. Operable disease (first-line treatment or neo-adjuvant therapy), 5. ECOG, Performance Status ≤ 2, 6. Decision of surgery validated in Multidisciplinary Consultation Meeting, 7. Reports of the non-opposition documented in the patient file before any procedure specific to the study, 8. Affiliation to system of Social Security (accordance with article L1121-11 of the Code of Public Health). Exclusion Criteria:

1. Metastatic disease from the onset or relapse 2. Participation in another study involving a similar geriatric assessment. 3. Geographic, familial, social, psychological or psychiatric factors that make the patient incapable of undergoing the study's follow-up and procedures. 4. Persons deprived of liberty or placed under judicial protection

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut Bergonié
  • Collaborator
    • Ministry of Health, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Cécile MERTENS, MD, 0556337828, c.mertens@bordeaux.unicancer.fr

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