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Clinical Trial NCT06022159 (HYPOSARC) for Soft Tissue Sarcoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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. (HYPOSARC) Phase 2 48 Randomized
Clinical Trial NCT06022159 (HYPOSARC) is designed to study Treatment for Soft Tissue Sarcoma. It is a Phase 2 interventional study that is recruiting, having started on 28 November 2023, with plans to enroll 48 participants. Led by Institut Claudius Regaud, it is expected to complete by 1 May 2029. The latest data from ClinicalTrials.gov was last updated on 5 June 2025.
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 hypofr...
Show MoreOfficial 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.
Conditions
Soft Tissue SarcomaOther Study IDs
- HYPOSARC
- 23 SARC 01
NCT ID Number
Start Date (Actual)
2023-11-28
Last Update Posted
2025-06-05
Completion Date (Estimated)
2029-05
Enrollment (Estimated)
48
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Soft Tissue Sarcoma
Limb soft tissue SARComa
Trunk soft tissue SARComa
Aged population
"Fragile" population
hypofractionated radiation therapy
Limb soft tissue SARComa
Trunk soft tissue SARComa
Aged population
"Fragile" population
hypofractionated radiation therapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalRadiation therapy followed by surgery | Hypofractionated Radiation Therapy The Hypofractionated Intensity-Modulated Radiation Therapy will be delivered in 5 fractions of 6 Gy each on the Planning Target Volume (PTV). The total dose of 30 Gy will be administered in approximately 1 week. Conservative treatment A wide en bloc resection is required (amputation is excluded) while ensuring the best functional preservation. The surgical procedure will take place about 1,5 to 2 months after the end of the radiation therapy. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery. | 6 month for each patient |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 3 years for each patient | |
Surgical complications evaluated according to NCI CTC AE V5 criteria. | 3 years for each patient | |
Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent. | 3 years for each patient | |
Healing time defined as the time between the date of surgery and the date of complete healing. | 3 years for each patient | |
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30). | 3 years for each patient | |
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14). | 3 years for each patient | |
Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire. | 3 years for each patient | |
Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire. | 3 years for each patient | |
Geriatric parameters evaluated using the G-CODE questionnaire. | 3 years for each patient | |
Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification. | 3 years for each patient |
Participation Assistant
Eligibility Criteria
Eligible Ages
Older Adult
Minimum Age
65 Years
Eligible Sexes
All
- Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk.
- Indication for neo-adjuvant or adjuvant radiotherapy.
- 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".
- Patient affiliated to a Social Health Insurance in France.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures.
- Retroperitoneal, ORL and visceral sarcomas.
- Previous radiotherapy in the area.
- Metastatic disease.
- Concomitant or sequential chemotherapy.
- Patient requiring total surgery (amputation).
- Other cancer under treatment.
- Any condition or pathology contraindicating MRI.
- Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure.
- Patients included in another therapeutic interventional trial.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Institut Claudius RegaudStudy Central Contact
Contact: Justine ATTAL KHALIFA, 05 31 15 54 38, [email protected]
11 Study Locations in 1 Countries
Institut Bergonie, Bordeaux, France
Pauline GILLON, Contact, 05 56 33 33 43, [email protected]
Recruiting
Centre Oscar Lambret, Lille, France
Abel CORDOBA LARGO, Contact, 03 20 29 59 59, [email protected]
Recruiting
Centre Leon Berard, Lyon, France
Waisse WAISSI, Contact, 04 78 78 28 28, [email protected]
Recruiting
Institut Regional Du Cancer de Montpellier, Montpellier, France
Carmen LLACER-MOSCARDO, Contact, 04 67 61 37 79, [email protected]
Recruiting
Institut Curie, Paris, France
Sylvie HELFRE, Contact, 01 44 32 46 25, [email protected]
Not yet recruiting
Chu de Poitiers, Poitiers, France
Sarah GARCIA MOLINA, Contact, 05 49 44 44 44, [email protected]
Recruiting
Institut de Cancerologie de L'Ouest, Saint-Herblain, France
Augustin MERVOYER, Contact, 02 40 67 99 00, [email protected]
Recruiting
Chu de Toulouse, Toulouse, France
Louis COURTOT, Contact, 05 61 77 21 04, [email protected]
Recruiting
IUCT-O, Toulouse, France
Justine ATTAL KHALIFA, Contact, 05 31 15 54 38, [email protected]
Recruiting
Institut Gustave Roussy, Villejuif, France
Cécile LE PECHOUX, Contact, 01 42 11 42 11, [email protected]
Recruiting