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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.

Study acronym: HYPOSARC
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 2, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 11 sitesv15
  2. Enrollment target: 70 to 48
    • Interventions: Patient will undergo surgery before receive the adjuvant hypofractionated radiation therapy (40 Gy in 15 fractions). (Procedure), Patients… to Conservative treatment (Procedure), Hypofractionated Radiation Therapy (Radiation)
    • Study arms: 2 to 1
    • Study title shortened, about 2 words
    v14
  3. Site details revised at 1 of 11 sitesv13
  4. Site details revised at 1 of 11 sitesv12
  5. Site details revised at 1 of 11 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Site details revised at 1 of 11 sitesv10
  2. Site contacts updated at 1 of 11 sitesv9
  3. Site details revised at 1 of 11 sitesv8
  4. Site details revised at 1 of 11 sitesv7
  5. Site details revised at 1 of 11 sitesv6
  6. Site details revised at 1 of 11 sitesv5
  7. Start date changed from estimate of Nov 2023 to Nov 28, 2023v4
  8. Site details revised at 1 of 11 sitesv3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2023 to Nov 2023
    • Site details revised at 11 of 11 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Institut Claudius Regaud
76 trials monitored
See 4 trials at risk
Sarcoma
1,026 trials monitored
See 67 trials at risk
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 hypofractionated radiation therapy prior to conservative surgery. Each patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery).
Trial Details
NCT Number NCT06022159
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)		 Soft Tissue Sarcoma
Related terms Sarcoma
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov