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RecruitingNCT07071727SCOPES IIUpdated Feb 19, 2026

Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas

An interventional study of Preoperative radiotherapy in Sarcoma of Soft Tissue, Sarcoma and Sarcoma, Soft Tissue, sponsored by The Netherlands Cancer Institute. Recruiting at 6 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

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

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Keywords

  • preoperative radiotherapy
  • radiotherapy
03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's planned enrollment of 150 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

The Netherlands Cancer Institute is the lead sponsor of 224 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed intermediate to high grade soft tissue sarcoma localized to the head and neck area, to the trunk and chest wall or to the extremities, for which the standard treatment is a combination of and radiotherapy and surgery (deep seated and/or ≥ 5cm in largest tumor diameter and/or an anticipated close resection margin and/or grade II/III according to the FNCLCC definition);
  • Absence of regional and/or distant disease. Patients must be staged by at least a CT scan of the chest. Staging may also be performed by FDG-PET scanning and/or total body MRI scans;
  • WHO Performance Status ≤ 2;
  • Able and willing to undergo preoperative radiotherapy;
  • Able and willing to undergo definitive surgery;
  • Able and willing to comply with regular follow-up visits;
  • Able and willing to complete patient reported outcome questionnaires (health-related quality of life and cost effectiveness);
  • Able and willing to undergo randomization;
  • Age ≥ 18 years;
  • Signed written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Prior malignancies; except another malignancy and disease-free for ≥ 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma;
  • Patients with locally recurrent sarcomas, regardless of the management of the first sarcoma diagnosis;
  • Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas;
  • Myxoid liposarcomas, because they have shown to be exquisitely sensitive to a lower dose of radiation as compared to the 2 regimens tested in this trial.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
  • Female patients who are pregnant;
  • Intention to perform an isolated limb perfusion, instead of a tumor resection;
  • Neoadjuvant chemotherapy both before and after radiotherapy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study 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.

    Radiation: Preoperative radiotherapy

  • 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.

    Radiation: Preoperative radiotherapy

Interventions

  • RadiationPreoperative radiotherapy

    preoperative radiotherapy

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What researchers measure

Primary outcomes

  1. The short-term toxicity

    wound complications

    Time frame: within 120 days post-surgery

Secondary outcomes

  1. Local control

    local failure after surgery

    Time frame: During follow up (5 years)

  2. Long-term toxicity

    fibrosis, edema, joint stiffness and bone fractures

    Time frame: During follow-up (5 years)

  3. Not operated patients

    Outcome of patients that were irradiated per randomization but eventually were not operated upon in conjunction to the reasons why the operation was not executed

    Time frame: During follow-up (5 years)

07

Study locations

2 of 6 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07071727
Lead sponsor
The Netherlands Cancer Institute
Collaborators
Radboud University Medical Center, University Medical Center Groningen, Leiden University Medical Center, Amsterdam UMC, Maastro Clinic, The Netherlands
Responsible party
Sponsor
First posted
Jul 17, 2025
Start date
Dec 11, 2025
Primary completion
Nov 1, 2028 (estimated)
Completion
Nov 1, 2033 (estimated)
Last update
Feb 19, 2026

Study contacts

Lisette M Wiltink, MD, PhD
Contact
l.m.wiltink@lumc.nl
+31205129111
R L M Haas, MD, PhD
Contact
r.haas@nki.nl
0205129111

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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