Sarcoma of Soft TissueSCOPES IINCT07071727
Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas
A study testing Preoperative radiotherapy in people with Sarcoma of Soft Tissue and Sarcoma, run by The Netherlands Cancer Institute at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma of Soft Tissue, Sarcoma, Sarcoma, Soft Tissue
- What is being tested?
- Preoperative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesNetherlands
- Study dates
- 11 Dec 2025to 1 Nov 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Not yet recruiting
Netherlands Cancer Institute
Amsterdam, 2141NK
L M Wiltink, MD PhD, 0205129111, l.m.wiltink@lumc.nl
- Recruiting
AUMC
Amsterdam
Balgobind, +31 20 5669111, b.v.balgobind@amsterdamumc.nl
- Not yet recruiting
UMCG
Groningen
Ubbels, +31 50 361 6161, j.f.ubbels@umcg.nl
- Not yet recruiting
LUMC
Leiden
Krol, +31 71 526 9111, a.d.g.krol@lumc.nl
- Recruiting
Maastro
Maastricht
Wesseling, +31884455600, frederik.wesseling@maastro.nl
- Not yet recruiting
RadboudUMC
Nijmegen
Braam, +3124 361 11 11, p.braam@radboudumc.nl
About this study
Official title: Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a Second Randomized Phase II Clinical Trial
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.
- Conditions
- Sarcoma of Soft Tissue, Sarcoma, Sarcoma, Soft Tissue
- Being tested
- Preoperative radiotherapy
- Keywords
- preoperative radiotherapy, radiotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative radiotherapyRadiation
preoperative radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Other | 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. Receives: Radiation: Preoperative radiotherapy |
| Arm B | Other | 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. Receives: Radiation: Preoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The short-term toxicity
wound complications
Measured: within 120 days post-surgery
Secondary outcomes (3)
Local control
local failure after surgery
Measured: During follow up (5 years)
Long-term toxicity
fibrosis, edema, joint stiffness and bone fractures
Measured: During follow-up (5 years)
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
Measured: During follow-up (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start11 Dec 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoma of Soft TissueStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization between two study arms: arm A of 14 x 3 Gy in 3 weeks and arm B of 5 x 6 Gy in one week.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, University Medical Center Groningen, Leiden University Medical Center, Amsterdam UMC, Maastro Clinic, The Netherlands
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071727
- Sponsor's protocol ID
- M24SCT
- Other IDs
- NL009842
- Acronym
- SCOPES II
- Status last verified
- Feb 2026
- First submitted
- 8 Jul 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Foppele GF, Fiocco M, Husson O, Kramer A, Retel VP, van der Noort V, Bovee JV, Feeney G, Ubbels FJF, Braam PM, Balgobind B, De Vries K, Wesseling FW, Rutkowski P, Spalek M, Haas RL, Wiltink LM. SCOPES-II: short course of preoperative radiotherapy in head and neck, trunk and extremity soft tissue sarcomas - study protocol for a second randomised phase II clinical trial. BMJ Open. 2026 Sep 23;16(9):e117842. doi: 10.1136/bmjopen-2026-117842.
PubMed 42778256
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a Second Randomized Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07071727
- Acronym / sponsor ID
- SCOPES II / M24SCT
- Conditions
- Sarcoma of Soft Tissue, Sarcoma, Sarcoma, Soft Tissue
- Keywords
- preoperative radiotherapy, radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, University Medical Center Groningen, Leiden University Medical Center, Amsterdam UMC, Maastro Clinic, The Netherlands
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2033 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization between two study arms: arm A of 14 x 3 Gy in 3 weeks and arm B of 5 x 6 Gy in one week.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | Radiation: Preoperative radiotherapyArm 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. |
| Arm B | Other | Radiation: Preoperative radiotherapyArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative radiotherapypreoperative radiotherapy | Radiation | Arm A, Arm B |
Primary outcome
The short-term toxicity
Time frame: within 120 days post-surgery
wound complications
3 secondary outcomes
Local control
Time frame: During follow up (5 years)
Long-term toxicity
Time frame: During follow-up (5 years)
Not operated patients
Time frame: During follow-up (5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Derived from this study: PubMed 42778256Foppele GF, Fiocco M, Husson O, Kramer A, Retel VP, van der Noort V, Bovee JV, Feeney G, Ubbels FJF, Braam PM, Balgobind B, De Vries K, Wesseling FW, Rutkowski P, Spalek M, Haas RL, Wiltink LM. SCOPES-II: short course of preoperative radiotherapy in head and neck, trunk and extremity soft tissue sarcomas - study protocol for a second randomised phase II clinical trial. BMJ Open. 2026 Sep 23;16(9):e117842. doi: 10.1136/bmjopen-2026-117842.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative radiotherapy in people with Sarcoma of Soft Tissue and Sarcoma, run by The Netherlands Cancer Institute at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisette M Wiltink, MD, PhD (+31205129111, l.m.wiltink@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The short-term toxicity (time frame: within 120 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07071727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.