Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas

Sponsor
The Netherlands Cancer Institute
Study ID
NCT07071727
Status
Recruiting
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Conditions

  • Sarcoma
  • Sarcoma of Soft Tissue
  • Sarcoma, Soft Tissue

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Preoperative radiotherapy — RADIATION
    preoperative radiotherapy

Study Details

Based upon the preliminary data derived from first SCOPES clinical trial and the results of patients treated during the recent COVID-19 pandemic, patients with soft tissue sarcomas (STS) can be preoperatively irradiated in a modestly hypofractionated schedule of 14 x 3 Gy. From a toxicity and efficacy point of view, this regimen equals the outcomes after a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Moreover, the rationale for investigating (modest) hypofractionation in the clinic comes both from a logistic point of view (patient convenience and a lower pressure on radiotherapy equipment), form prior phase II clinical evidence and from (cellular) radiobiological observations. There is phase II trial evidence suggesting that even more (ultra-) hypofractionation to 5 x 6 Gy is also safe and effective. Within this study, patients will be randomized to receive either the modestly hypofractionated conventional schedule of 14 x 3 Gy or an even shorter preoperative regimen of 5 x 6 Gy, in the hypothesis that both the postoperative wound complication rate until 120 days after surgery, as well as the local control probability at two years are comparable in both arms.

Key Dates

First listed
Jul 17, 2025
Start date
Dec 11, 2025
Status verified
Feb 2026
Primary completion
Nov 1, 2028
Completion
Nov 1, 2033

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Arm A
    Arm A: Preoperative radiotherapy to a total dose of 42 Gy in 14 once daily fractions of 3 Gy, in an overall treatment time of three weeks.
  • Other: Arm B
    Arm B: Preoperative radiotherapy to a total dose of 30 Gy in 5 once daily fractions of 6 Gy, in an overall treatment time of one week.

Primary Outcome Measure

The short-term toxicity [ Time Frame: within 120 days post-surgery ]

Central Contacts

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