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

Institut Bergonié

Status: Active, not recruiting

Conditions: Soft Tissue Sarcoma Adult

Treatments: Procedure: Geriatric assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT03077178

IB2016-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 70+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Prospective cohort

Experimental group

Description:

Geriatric assessment

Treatment:

Procedure: Geriatric assessment