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

Not Applicable

Active, not recruiting

• Conditions: Soft Tissue Sarcoma Adult
• Interventions: Procedure: Geriatric assessment

• Registration Number: NCT03077178
• Lead Sponsor: Institut Bergonié

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.

Study Timeline

• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-10
• Study Start: 2017-11-30
• Primary Completion: 2023-01-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective cohort	Geriatric assessment	Geriatric assessment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Functional status assessment (MST)	Change from baseline until 36 months after surgery	Muskuloskeletal Tumor Society (MST) scale
Geriatric parameters assessment - G8	baseline	G8 (onco-geratic screening score)
Functional status assessment (TESS)	Change from baseline until 36 months after surgery	Toronto Extremity salvage score (TESS) Scale
Geriatric parameters assessment - ADL	Change from baseline until 36 months after surgery	ADL (Activities in Daily Living)
Geriatric parameters assessment - IADL	Change from baseline until 36 months after surgery	IADL (Instrumental Activities in Daily Living)
Quality of life assessment QLQ-C30	Change from baseline until 36 months after surgery	Quality of life questionnaire QLQ-C30
Time until deterioration of physical functioning	Change until 36 months after surgery	Quality of life questionnaire QLQ-C30
Geriatric parameters assessment - MNA	Change from baseline until 36 months after surgery	MNA (Mini Nutritional Assessment)
Geriatric parameters assessment - GDS 15	Change from baseline until 36 months after surgery	GDS 15(Geriatric Depression Scale).
Geriatric parameters assessment - MMSE	Change from baseline until 36 months after surgery	MMSE (Mini Mental Status)
Pain Assessment	Change from Baseline until 36 months after surgery	Brief Pain Inventory (BPI) questionnaire
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 - CIRS-G	baseline	CIRS-G (Cumulative Illness Rating Scale - Geriatrics)

Trial Locations

Locations (1)

Institut Bergonié; 🇫🇷 Bordeaux, France