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NCT Number: NCT07071727

Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas

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.

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Key information

Conditions

Sarcoma of Soft Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma Sarcoma, Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AUMC, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

preoperative radiotherapy

Radiation

preoperative radiotherapy

Primary outcomes

  1. The short-term toxicity

    Time frame: within 120 days post-surgery

    wound complications

Secondary outcomes

  1. Local control

    Time frame: During follow up (5 years)

    local failure after surgery

  2. Long-term toxicity

    Time frame: During follow-up (5 years)

    fibrosis, edema, joint stiffness and bone fractures

  3. Not operated patients

    Time frame: During follow-up (5 years)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lisette M Wiltink, MD, PhD

CONTACT

[email protected]

+31205129111

R L M Haas, MD, PhD

CONTACT

[email protected]

0205129111

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • Amsterdam UMC
  • Leiden University Medical Center
  • Maastro Clinic, The Netherlands
  • Radboud University Medical Center
  • University Medical Center Groningen

Registry information

Official study title

Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a Second Randomized Phase II Clinical Trial

Acronym: SCOPES II

Important dates

Study start
2025
Primary completion
2028
Study completion
2033
First posted
Jul 17, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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