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NCT Number: NCT03077178

Impact of Locoregional Treatment of Soft Tissue Sarcoma on 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Soft Tissue Sarcoma Adult Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonié

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Geriatric assessment

Procedure

Geriatric assessment, questionnaire assessment

Primary outcomes

  1. Change in Physical functioning assessment

    Time frame: Change from baseline until 36 months after surgery

    Quality of life questionnaire QLQ-C30

Secondary outcomes

  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. Quality of life assessment QLQ-C30

    Time frame: Change from baseline until 36 months after surgery

    Quality of life questionnaire QLQ-C30

  4. Quality of life assessment QLQ-EDL-14

    Time frame: Change from baseline until 36 months after surgery

    Quality of life questionnaire QLQ-EDL-14

  5. Geriatric parameters assessment - G8

    Time frame: baseline

    G8 (onco-geratic screening score)

  6. Surgical complications

    Time frame: Change from Day 0 until 12 months after surgery

    classification Clavien Dindo

  7. OS

    Time frame: Change from Day 0 until 36 months after surgery

    Overall Survival

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: SARCOLD

Important dates

Study start
2017
Primary completion
2023
Study completion
2026
First posted
Mar 10, 2017
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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