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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
Recruitment Status : Recruiting
First Posted : September 1, 2023
Last Update Posted : December 8, 2023
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

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

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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

Resource links provided by the National Library of Medicine


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).





Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Surgical complications evaluated according to NCI CTC AE V5 criteria. [ Time Frame: 3 years for each patient ]
  3. Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent. [ Time Frame: 3 years for each patient ]
  4. Healing time defined as the time between the date of surgery and the date of complete healing. [ Time Frame: 3 years for each patient ]
  5. Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30). [ Time Frame: 3 years for each patient ]
  6. Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14). [ Time Frame: 3 years for each patient ]
  7. Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire. [ Time Frame: 3 years for each patient ]
  8. Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire. [ Time Frame: 3 years for each patient ]
  9. Geriatric parameters evaluated using the G-CODE questionnaire. [ Time Frame: 3 years for each patient ]
  10. 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 ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Contacts
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Contact: Justine ATTAL KHALIFA 05 31 15 54 38 AttalKhalifa.Justine@iuct-oncopole.fr

Locations
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France
Institut Bergonie Not yet recruiting
Bordeaux, France
Contact: Pauline GILLON    05 56 33 33 43    p.gillon@bordeaux.unicancer.fr   
Centre Oscar Lambret Not yet 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: Raphael SERRE    05 55 05 62 69    raphael.serre@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 Not yet 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 Not yet 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   
Sponsors and Collaborators
Institut Claudius Regaud
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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: December 8, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
Soft Tissue Sarcoma
Limb soft tissue SARComa
Trunk soft tissue SARComa
Aged population
"Fragile" population
hypofractionated radiation therapy
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms