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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue Sarcoma Adult
• Intervention / Treatment: Procedure: Geriatric 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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cécile MERTENS, MD; Phone Number: 0556337828; Email: c.mertens@bordeaux.unicancer.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • Recruiting
    • Institut Bergonie
    • Contact: Cécile MERTENS, MD
    • Principal Investigator: Cécile MERTENS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective cohort; Geriatric assessment	Procedure: Geriatric assessment; Geriatric assessment, questionnaire assessment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Collaborators: Ministry of Health, France

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Anticipated): March 15, 2022
• Study Completion (Anticipated): March 15, 2023

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Surgery; Geriatrics; Soft Tissue Sarcoma; Elderly Patient; Functional Impact
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: IB2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No