Soft Tissue Sarcoma AdultSARCOLDNCT03077178
Impact of Locoregional Treatment of Soft Tissue Sarcoma on Status of Patients Aged 70 Years and Over
A study testing Geriatric assessment in people with Soft Tissue Sarcoma Adult, run by Institut Bergonié at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Soft Tissue Sarcoma Adult
- What is being tested?
- Geriatric assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2017to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Soft Tissue Sarcoma Adult
- Being tested
- Geriatric assessment
- Keywords
- Soft Tissue Sarcoma, Surgery, Functional Impact, Elderly Patient, Geriatrics
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric assessmentProcedure or surgery
Geriatric assessment, questionnaire assessment
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Experimental | Geriatric assessment Receives: Procedure: Geriatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical functioning assessment
Quality of life questionnaire QLQ-C30
Measured: Change from baseline until 36 months after surgery
Secondary outcomes (7)
Functional status assessment (TESS)
Toronto Extremity salvage score (TESS) Scale
Measured: Change from baseline until 36 months after surgery
Functional status assessment (MST)
Muskuloskeletal Tumor Society (MST) scale
Measured: Change from baseline until 36 months after surgery
Quality of life assessment QLQ-C30
Quality of life questionnaire QLQ-C30
Measured: Change from baseline until 36 months after surgery
Quality of life assessment QLQ-EDL-14
Quality of life questionnaire QLQ-EDL-14
Measured: Change from baseline until 36 months after surgery
Geriatric parameters assessment - G8
G8 (onco-geratic screening score)
Measured: baseline
Surgical complications
classification Clavien Dindo
Measured: Change from Day 0 until 12 months after surgery
OS
Overall Survival
Measured: Change from Day 0 until 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start30 Nov 2017
- Primary completion15 Jan 2023
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077178
- Sponsor's protocol ID
- IB2016-01
- Acronym
- SARCOLD
- Status last verified
- Jan 2026
- First submitted
- 20 Feb 2017
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status of Patients Aged 70 Years and Over
- ClinicalTrials.gov ID
- NCT03077178
- Acronym / sponsor ID
- SARCOLD / IB2016-01
- Conditions
- Soft Tissue Sarcoma Adult
- Keywords
- Soft Tissue Sarcoma, Surgery, Functional Impact, Elderly Patient, Geriatrics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- Mar 2026 (estimated)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | Experimental | Procedure: Geriatric assessmentGeriatric assessment |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric assessmentGeriatric assessment, questionnaire assessment | Procedure or surgery | Prospective cohort |
Primary outcome
Change in Physical functioning assessment
Time frame: Change from baseline until 36 months after surgery
Quality of life questionnaire QLQ-C30
7 secondary outcomes
Functional status assessment (TESS)
Time frame: Change from baseline until 36 months after surgery
Functional status assessment (MST)
Time frame: Change from baseline until 36 months after surgery
Quality of life assessment QLQ-C30
Time frame: Change from baseline until 36 months after surgery
Quality of life assessment QLQ-EDL-14
Time frame: Change from baseline until 36 months after surgery
Geriatric parameters assessment - G8
Time frame: baseline
Surgical complications
Time frame: Change from Day 0 until 12 months after surgery
OS
Time frame: Change from Day 0 until 36 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric assessment in people with Soft Tissue Sarcoma Adult, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical functioning assessment (time frame: Change from baseline until 36 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.