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. (HYPOSARC)
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| ClinicalTrials.gov Identifier: NCT06022159 |
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Recruitment Status :
Recruiting
First Posted : September 1, 2023
Last Update Posted : May 3, 2024
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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 Type : | Interventional (Clinical Trial) |
| Estimated 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. |
| Actual Study Start Date : | November 28, 2023 |
| Estimated Primary Completion Date : | September 2026 |
| Estimated Study Completion Date : | May 2029 |
| 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). |
- 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 ]
- 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 ]
- Surgical complications evaluated according to NCI CTC AE V5 criteria. [ Time Frame: 3 years for each patient ]
- Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent. [ Time Frame: 3 years for each patient ]
- Healing time defined as the time between the date of surgery and the date of complete healing. [ Time Frame: 3 years for each patient ]
- Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30). [ Time Frame: 3 years for each patient ]
- Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14). [ Time Frame: 3 years for each patient ]
- Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire. [ Time Frame: 3 years for each patient ]
- Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire. [ Time Frame: 3 years for each patient ]
- Geriatric parameters evaluated using the G-CODE questionnaire. [ Time Frame: 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. [ Time Frame: 3 years for each patient ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022159
| Contact: Justine ATTAL KHALIFA | 05 31 15 54 38 | AttalKhalifa.Justine@iuct-oncopole.fr |
| France | |
| Institut Bergonie | Recruiting |
| Bordeaux, France | |
| Contact: Pauline GILLON 05 56 33 33 43 p.gillon@bordeaux.unicancer.fr | |
| Centre Oscar Lambret | Recruiting |
| Lille, France | |
| Contact: Abel CORDOBA LARGO 03 20 29 59 59 a-cordoba@o-lambret.fr | |
| Chu de Limoges | Not yet recruiting |
| Limoges, France | |
| Contact: Hélène ORLIAC 05 55 05 62 68 helene.orliac@chu-limoges.fr | |
| Centre Leon Berard | Not yet recruiting |
| Lyon, France | |
| Contact: Waisse WAISSI 04 78 78 28 28 waisse.waissi@lyon.unicancer.fr | |
| Institut Regional Du Cancer de Montpellier | Recruiting |
| Montpellier, France | |
| Contact: Carmen LLACER-MOSCARDO 04 67 61 37 79 carmen.llacer@icm.unicancer.fr | |
| Institut Curie | Not yet recruiting |
| Paris, France | |
| Contact: Sylvie HELFRE 01 44 32 46 25 sylvie.helfre@curie.net | |
| Chu de Poitiers | Recruiting |
| Poitiers, France | |
| Contact: Sarah GARCIA MOLINA 05 49 44 44 44 sarah.garcia-molina@chu-poitiers.fr | |
| Institut de Cancerologie de L'Ouest | Not yet recruiting |
| Saint-Herblain, France | |
| Contact: Augustin MERVOYER 02 40 67 99 00 augustin.mervoyer@ico.unicancer.fr | |
| Chu de Toulouse | Recruiting |
| Toulouse, France | |
| Contact: Louis COURTOT 05 61 77 21 04 courtot.l@chu-toulouse.fr | |
| IUCT-O | Recruiting |
| Toulouse, France | |
| Contact: Justine ATTAL KHALIFA 05 31 15 54 38 attalkhalifa.justine@iuct-oncopole.fr | |
| Institut Gustave Roussy | Not yet recruiting |
| Villejuif, France | |
| Contact: Cécile LE PECHOUX 01 42 11 42 11 cecile.lepechoux@gustaveroussy.fr | |
| Responsible Party: | Institut Claudius Regaud |
| ClinicalTrials.gov Identifier: | NCT06022159 |
| Other Study ID Numbers: |
23 SARC 01 |
| First Posted: | September 1, 2023 Key Record Dates |
| Last Update Posted: | May 3, 2024 |
| Last Verified: | May 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Soft Tissue Sarcoma Limb soft tissue SARComa Trunk soft tissue SARComa |
Aged population "Fragile" population hypofractionated radiation therapy |
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Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |