Back to resultsA Study to Evaluate Pre- or Post-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa. (HYPOSARC)
Primary Purpose
Soft Tissue Sarcoma
Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery.
Patient will undergo surgery before receive the adjuvant hypofractionated radiation therapy (40 Gy in 15 fractions).
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring Soft Tissue Sarcoma, Limb soft tissue SARComa, Trunk soft tissue SARComa, Aged population, "Fragile" population, hypofractionated radiation therapy
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Sites / Locations
- Institut Bergonie
- Centre Oscar Lambret
- Chu de Limoges
- Centre Leon Berard
- Institut Regional Du Cancer de Montpellier
- Institut Curie
- Chu de Poitiers
- Institut de Cancerologie de L'Ouest
- Chu de Toulouse
- IUCT-ORecruiting
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Neo-adjuvant Cohort
Adjuvant Cohort
Arm Description
Outcomes
Primary Outcome Measures
The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.
Secondary Outcome Measures
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.
Surgical complications evaluated according to NCI CTC AE V5 criteria.
Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.
Healing time defined as the time between the date of surgery and the date of complete healing.
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).
Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.
Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.
Geriatric parameters evaluated using the G-CODE questionnaire.
Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification.
Full Information
NCT ID
NCT06022159
First Posted
August 16, 2023
Last Updated
October 19, 2023
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT06022159
Brief Title
A Study to Evaluate Pre- or Post-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.
Acronym
HYPOSARC
Official Title
Phase II Study Evaluating Pre- or Post-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
May 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 and 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 70 patients will be included in this study, divided in 2 groups (35 patients per arms): a neo-adjuvant cohort and an adjuvant cohort.
In the neo-adjuvant cohort, patients will receive an hypofractionated radiation therapy prior to surgery.
In the adjuvant cohort, patients will undergo a surgery before receive the hypofractionated radiation therapy.
Each patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery or surgery + radiotherapy).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
Keywords
Soft Tissue Sarcoma, Limb soft tissue SARComa, Trunk soft tissue SARComa, Aged population, "Fragile" population, hypofractionated radiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neo-adjuvant Cohort
Arm Type
Experimental
Arm Title
Adjuvant Cohort
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery.
Intervention Description
Early post-radiotherapy toxicity will then be assessed 1 month after the end of radiotherapy.
Post-operative follow-up: post-operative complications will be followed at 3 and 6 weeks post-surgery.
A visit at 6 months post-surgery will also be carried out to evaluate post-operative complications and late adverse effects of radiotherapy.
Long-term follow-up would also be performed every 6 months from the 6-month post-surgery visit up to 3 years post-surgery (M12, M18, M24, M30 and M36).
Intervention Type
Procedure
Intervention Name(s)
Patient will undergo surgery before receive the adjuvant hypofractionated radiation therapy (40 Gy in 15 fractions).
Intervention Description
Post-operative follow-up: postoperative complications will be followed at 3 and 6 weeks post-surgery (before the start of irradiation). Early post-radiotherapy toxicity will then be assessed 1 month after the end of radiotherapy.
A 6-month post-surgery check-up will also be carried out to assess post-operative complications and acute side effects of radiotherapy.
Long-term follow-up would also be performed every 6 months from the 6-month post-surgery visit up to 3 years post-surgery (M12, M18, M24, M30 and M36).
Primary Outcome Measure Information:
Title
The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.
Time Frame
6 month for each patient
Secondary Outcome Measure Information:
Title
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.
Time Frame
3 years for each patient
Title
Surgical complications evaluated according to NCI CTC AE V5 criteria.
Time Frame
3 years for each patient
Title
Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.
Time Frame
3 years for each patient
Title
Healing time defined as the time between the date of surgery and the date of complete healing.
Time Frame
3 years for each patient
Title
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).
Time Frame
3 years for each patient
Title
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).
Time Frame
3 years for each patient
Title
Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.
Time Frame
3 years for each patient
Title
Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.
Time Frame
3 years for each patient
Title
Geriatric parameters evaluated using the G-CODE questionnaire.
Time Frame
3 years for each patient
Title
Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification.
Time Frame
3 years for each patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justine ATTAL KHALIFA
Phone
05 31 15 54 38
Email
AttalKhalifa.Justine@iuct-oncopole.fr
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline GILLON
Phone
05 56 33 33 43
Email
p.gillon@bordeaux.unicancer.fr
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abel CORDOBA LARGO
Phone
03 20 29 59 59
Email
a-cordoba@o-lambret.fr
Facility Name
Chu de Limoges
City
Limoges
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphael SERRE
Phone
05 55 05 62 69
Email
raphael.serre@chu-limoges.fr
Facility Name
Centre Leon Berard
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waisse WAISSI
Phone
04 78 78 28 28
Email
waisse.waissi@lyon.unicancer.fr
Facility Name
Institut Regional Du Cancer de Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen LLACER-MOSCARDO
Phone
04 67 61 37 79
Email
carmen.llacer@icm.unicancer.fr
Facility Name
Institut Curie
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie HELFRE
Phone
01 44 32 46 25
Email
sylvie.helfre@curie.net
Facility Name
Chu de Poitiers
City
Poitiers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah GARCIA MOLINA
Phone
05 49 44 44 44
Email
sarah.garcia-molina@chu-poitiers.fr
Facility Name
Institut de Cancerologie de L'Ouest
City
Saint-Herblain
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Augustin MERVOYER
Phone
02 40 67 99 00
Email
augustin.mervoyer@ico.unicancer.fr
Facility Name
Chu de Toulouse
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis COURTOT
Phone
05 61 77 21 04
Email
courtot.l@chu-toulouse.fr
Facility Name
IUCT-O
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine ATTAL KHALIFA
Phone
05 31 15 54 38
Email
attalkhalifa.justine@iuct-oncopole.fr
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile LE PECHOUX
Phone
01 42 11 42 11
Email
cecile.lepechoux@gustaveroussy.fr
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Pre- or Post-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.
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