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

Primary Purpose

Soft Tissue Sarcoma Adult

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Geriatric assessment
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Soft Tissue Sarcoma Adult focused on measuring Soft Tissue Sarcoma, Surgery, Functional Impact, Elderly Patient, Geriatrics

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut BergoniéRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prospective cohort

Arm Description

Geriatric assessment

Outcomes

Primary Outcome Measures

Change in Physical functioning assessment
Quality of life questionnaire QLQ-C30

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2017
Last Updated
November 2, 2017
Sponsor
Institut Bergonié
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT03077178
Brief Title
Impact of Locoregional Treatment of Soft Tissue Sarcoma on Status of Patients Aged 70 Years and Over
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
March 15, 2022 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma Adult
Keywords
Soft Tissue Sarcoma, Surgery, Functional Impact, Elderly Patient, Geriatrics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged more than 70 years, Soft tissue sarcoma histologically proven, Sarcoma of the soft tissues of the lower limbs, Operable disease (first-line treatment or neo-adjuvant therapy), ECOG, Performance Status ≤ 2, Decision of surgery validated in Multidisciplinary Consultation Meeting, Reports of the non-opposition documented in the patient file before any procedure specific to the study, Affiliation to system of Social Security (accordance with article L1121-11 of the Code of Public Health). Exclusion Criteria: Metastatic disease from the onset or relapse Participation in another study involving a similar geriatric assessment. Geographic, familial, social, psychological or psychiatric factors that make the patient incapable of undergoing the study's follow-up and procedures. Persons deprived of liberty or placed under judicial protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile MERTENS, MD
Phone
0556337828
Email
c.mertens@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Simone MATHOULIN-PELISSIER, MD,PhD
Email
s.mathoulin@bordeaux.unicancer.fr
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile MERTENS, MD
First Name & Middle Initial & Last Name & Degree
Cécile MERTENS, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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