Soft Tissue Sarcoma Adult
Conditions
Keywords
Soft Tissue Sarcoma, Surgery, Functional Impact, Elderly Patient, Geriatrics
Brief summary
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
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
PROCEDUREGeriatric assessment
Geriatric assessment, questionnaire assessment
Sponsors
Institut Bergonié
Ministry of Health, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical functioning assessment | Change from baseline until 36 months after surgery | Quality of life questionnaire QLQ-C30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional status assessment (TESS) | Change from baseline until 36 months after surgery | Toronto Extremity salvage score (TESS) Scale |
| Functional status assessment (MST) | Change from baseline until 36 months after surgery | Muskuloskeletal Tumor Society (MST) scale |
| Quality of life assessment QLQ-C30 | Change from baseline until 36 months after surgery | Quality of life questionnaire QLQ-C30 |
| Quality of life assessment QLQ-EDL-14 | Change from baseline until 36 months after surgery | Quality of life questionnaire QLQ-EDL-14 |
| Geriatric parameters assessment - G8 | baseline | G8 (onco-geratic screening score) |
| Surgical complications | Change from Day 0 until 12 months after surgery | classification Clavien Dindo |
| OS | Change from Day 0 until 36 months after surgery | Overall Survival |
Countries
France
Outcome results
None listed