Clinical trial NCT06022159: A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.
Official title: Phase II Study Evaluating Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Keywords: Soft Tissue Sarcoma
Limb soft tissue SARComa
Trunk soft tissue SARComa
Aged population
"Fragile" population
hypofractionated radiation therapy
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Radiation therapy followed by surgery
Primary purpose: TREATMENT

Brief summary: This is a phase II, multicenter, non-randomized study.

The main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as "fragile" and treated for soft tissue sarcoma.

A maximum of 48 evaluable patients will be included in this study. The patients will receive an hypofractionated radiation therapy prior to conservative surgery.

Each patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery).


Eligibility criteria: Inclusion Criteria:

1. Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk.
2. Indication for neo-adjuvant or adjuvant radiotherapy.
3. Patient aged ≥ 70 years with a performance status ECOG ≤ 2 and/or aged 65 to 70 years with an ECOG of 2 and identified by the investigator as "fragile".
4. Patient affiliated to a Social Health Insurance in France.
5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures.

Exclusion Criteria:

1. Retroperitoneal, ORL and visceral sarcomas.
2. Previous radiotherapy in the area.
3. Metastatic disease.
4. Concomitant or sequential chemotherapy.
5. Patient requiring total surgery (amputation).
6. Other cancer under treatment.
7. Any condition or pathology contraindicating MRI.
8. Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure.
9. Patients included in another therapeutic interventional trial.
10. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Primary outcomes:
measure: The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.
timeFrame: 6 month for each patient
Secondary outcomes:
measure: Patients' disease-free survival defined as the time between the inclusion date and the occurrence of a carcinological event (local recurrence, distant metastasis) or death from any cause.
timeFrame: 3 years for each patient
measure: Surgical complications evaluated according to NCI CTC AE V5 criteria.
timeFrame: 3 years for each patient
measure: Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.
timeFrame: 3 years for each patient
measure: Healing time defined as the time between the date of surgery and the date of complete healing.
timeFrame: 3 years for each patient
measure: Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).
timeFrame: 3 years for each patient
measure: Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).
timeFrame: 3 years for each patient
measure: Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.
timeFrame: 3 years for each patient
measure: Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.
timeFrame: 3 years for each patient
measure: Geriatric parameters evaluated using the G-CODE questionnaire.
timeFrame: 3 years for each patient
measure: Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification.
timeFrame: 3 years for each patient
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: Chu de Limoges
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: Institut Regional Du Cancer de Montpellier
city: Paris
country: France
facility: Institut Curie
city: Poitiers
country: France
facility: Chu de Poitiers
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de L'Ouest
city: Toulouse
country: France
facility: Chu de Toulouse
city: Toulouse
country: France
facility: IUCT-O
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: