HYPOSARC: 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.

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06022159

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

6.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcoma	Procedure: Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery. Procedure: Patient will undergo surgery before receive the adjuvant hypofractionated radiation therapy (40 Gy in 15 fractions).	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

May 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neo-adjuvant Cohort	Procedure: Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery. 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).
Experimental: Adjuvant Cohort	Procedure: Patient will undergo surgery before receive the adjuvant hypofractionated radiation therapy (40 Gy in 15 fractions). 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).

Arm

Intervention/Treatment

Experimental: Neo-adjuvant Cohort

Procedure: Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery.

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).

Experimental: Adjuvant Cohort

Procedure: Patient will undergo surgery before receive the adjuvant hypofractionated radiation therapy (40 Gy in 15 fractions).

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).

Outcome Measures

Primary Outcome Measures

The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery. [6 month for each patient]

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. [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	Country
1	Institut Bergonie	Bordeaux	France
2	Centre Oscar Lambret	Lille	France
3	Chu de Limoges	Limoges	France
4	Centre Leon Berard	Lyon	France
5	Institut Regional Du Cancer de Montpellier	Montpellier	France
6	Institut Curie	Paris	France
7	Chu de Poitiers	Poitiers	France
8	Institut de Cancerologie de L'Ouest	Saint-Herblain	France
9	Chu de Toulouse	Toulouse	France
10	IUCT-O	Toulouse	France
11	Institut Gustave Roussy	Villejuif	France