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

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ClinicalTrials.gov Identifier: NCT03077178
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Adult Procedure: Geriatric assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status of Patients Aged 70 Years and Over
Actual Study Start Date : October 15, 2017
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : March 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prospective cohort
Geriatric assessment
Procedure: Geriatric assessment
Geriatric assessment, questionnaire assessment




Primary Outcome Measures :
  1. Change in Physical functioning assessment [ Time Frame: Change from baseline until 36 months after surgery ]
    Quality of life questionnaire QLQ-C30


Secondary Outcome Measures :
  1. Functional status assessment (TESS) [ Time Frame: Change from baseline until 36 months after surgery ]
    Toronto Extremity salvage score (TESS) Scale

  2. Functional status assessment (MST) [ Time Frame: Change from baseline until 36 months after surgery ]
    Muskuloskeletal Tumor Society (MST) scale

  3. Time until deterioration of physical functioning [ Time Frame: Change until 36 months after surgery ]
    Quality of life questionnaire QLQ-C30

  4. Quality of life assessment QLQ-C30 [ Time Frame: Change from baseline until 36 months after surgery ]
    Quality of life questionnaire QLQ-C30

  5. Quality of life assessment QLQ-EDL-14 [ Time Frame: Change from baseline until 36 months after surgery ]
    Quality of life questionnaire QLQ-EDL-14

  6. Geriatric parameters assessment - G8 [ Time Frame: baseline ]
    G8 (onco-geratic screening score)

  7. Geriatric parameters assessment - CIRS-G [ Time Frame: baseline ]
    CIRS-G (Cumulative Illness Rating Scale - Geriatrics)

  8. Geriatric parameters assessment - MNA [ Time Frame: Change from baseline until 36 months after surgery ]
    MNA (Mini Nutritional Assessment)

  9. Geriatric parameters assessment - ADL [ Time Frame: Change from baseline until 36 months after surgery ]
    ADL (Activities in Daily Living)

  10. Geriatric parameters assessment - IADL [ Time Frame: Change from baseline until 36 months after surgery ]
    IADL (Instrumental Activities in Daily Living)

  11. Geriatric parameters assessment - GDS 15 [ Time Frame: Change from baseline until 36 months after surgery ]
    GDS 15(Geriatric Depression Scale).

  12. Geriatric parameters assessment - MMSE [ Time Frame: Change from baseline until 36 months after surgery ]
    MMSE (Mini Mental Status)

  13. Pain Assessment [ Time Frame: Change from Baseline until 36 months after surgery ]
    Brief Pain Inventory (BPI) questionnaire

  14. Surgical complications [ Time Frame: Change from Day 0 until 12 months after surgery ]
    classification Clavien Dindo

  15. OS [ Time Frame: Change from Day 0 until 36 months after surgery ]
    Overall Survival



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077178


Contacts
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Contact: Cécile MERTENS, MD 0556337828 c.mertens@bordeaux.unicancer.fr
Contact: Simone MATHOULIN-PELISSIER, MD,PhD s.mathoulin@bordeaux.unicancer.fr

Locations
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France
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Cécile MERTENS, MD         
Principal Investigator: Cécile MERTENS, MD         
Sponsors and Collaborators
Institut Bergonié
Ministry of Health, France

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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT03077178     History of Changes
Other Study ID Numbers: IB2016-01
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Bergonié:
Soft Tissue Sarcoma
Surgery
Functional Impact
Elderly Patient
Geriatrics
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms