Clinical trial NCT03077178: Impact of Locoregional Treatment of Soft Tissue Sarcoma on Status of Patients Aged 70 Years and Over
Official title: Evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status of Patients Aged 70 Years and Over
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Soft Tissue Sarcoma Adult
Keywords: Soft Tissue Sarcoma
Surgery
Functional Impact
Elderly Patient
Geriatrics
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2017-03-10
Enrollment: 25
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical functioning assessment
timeFrame: Change from baseline until 36 months after surgery
Secondary outcomes:
measure: Functional status assessment (TESS)
timeFrame: Change from baseline until 36 months after surgery
measure: Functional status assessment (MST)
timeFrame: Change from baseline until 36 months after surgery
measure: Time until deterioration of physical functioning
timeFrame: Change until 36 months after surgery
measure: Quality of life assessment QLQ-C30
timeFrame: Change from baseline until 36 months after surgery
measure: Quality of life assessment QLQ-EDL-14
timeFrame: Change from baseline until 36 months after surgery
measure: Geriatric parameters assessment - G8
timeFrame: baseline
measure: Geriatric parameters assessment - CIRS-G
timeFrame: baseline
measure: Geriatric parameters assessment - MNA
timeFrame: Change from baseline until 36 months after surgery
measure: Geriatric parameters assessment - ADL
timeFrame: Change from baseline until 36 months after surgery
measure: Geriatric parameters assessment - IADL
timeFrame: Change from baseline until 36 months after surgery
measure: Geriatric parameters assessment - GDS 15
timeFrame: Change from baseline until 36 months after surgery
measure: Geriatric parameters assessment - MMSE
timeFrame: Change from baseline until 36 months after surgery
measure: Pain Assessment
timeFrame: Change from Baseline until 36 months after surgery
measure: Surgical complications
timeFrame: Change from Day 0 until 12 months after surgery
measure: OS
timeFrame: Change from Day 0 until 36 months after surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
Study officials:
References: