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

Soft Tissue Sarcoma Adult Clinical Trial

— SARCOLD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03077178
• Other study ID #: IB2016-01
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2017
• Last updated: November 2, 2017
• Start date: October 15, 2017
• Est. completion date: March 15, 2023

Study information

• Verified date: November 2017
• Source: Institut Bergonié
• Contact: Cécile MERTENS, MD
• Phone: 0556337828
• Email: c.mertens[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma Adult

Intervention

Procedure:
• Geriatric assessment
Geriatric assessment, questionnaire assessment

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

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