Soft Tissue SarcomasSCOPESNCT04425967
Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas
A study testing pre-operative radiotherapy in people with Soft Tissue Sarcomas, run by The Netherlands Cancer Institute at 4 sites in Netherlands.
Trial summary
Currently, soft tissue sarcomas (STS) are preoperatively irradiated in a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Recent radiobiological investigations, however, suggest sensitivity to (modest) hypofractionation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcomas
- What is being tested?
- pre-operative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 4 sitesNetherlands
- Study dates
- 25 Jun 2021to 1 May 2036
- 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 newly diagnosed intermediate to high grade soft tissue sarcoma localized to the extremities, trunk and chest wall or the head and neck area, 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 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. Patients with an uncertain metastatic status (e.g. small indifferent lung nodules) and patients with a low metastatic burden not precluding the application of both preoperative radiotherapy and definitive surgery, are allowed to participate;
- 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 recurrent sarcomas who underwent prior radiotherapy to the target lesion (if the primary sarcoma was managed by surgery only and no perioperative RT, patients are eligible);
- Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas;
- 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 to be scheduled between end of radiotherapy and definitive surgery (neoadjuvant chemotherapy before radiotherapy is allowed);
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Universitair Medisch Centrum Groningen
Groningen, 9713GZ
Leids Universitair Medisch Centrum
Leiden, 2333ZA
Radboudumc
Nijmegen, 6525GA
Erasmus Medical Centre
Rotterdam
About this study
Official title: Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a Randomized Phase II Clinical Trial
Currently, soft tissue sarcomas (STS) are preoperatively irradiated in a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Recent radiobiological investigations, however, suggest sensitivity to (modest) hypofractionation. Within this study, patients will be randomized to receive either the conventional schedule of 25 x 2 Gy or a shorter preoperative regimen of 14 x 3 Gy, in the hypothesis that both the postoperative wound complication rate until 30 days after surgery, as well as the local control probability at two years are comparable in both arms.
Read the detailed description
Surgery is the cornerstone in the treatment of non-metastatic sarcomas. Whenever feasible the resection should include a free surgical margin providing a rim of uninvolved tissue surrounding the tumor. In most deep located tumors however, to preserve essential neurovascular and bone structures and thus to preserve function, the margins are often limited. High grade tumors are, even with wider margins, at higher risk of local failure. Radiotherapy can reduce this risk of local failure.
Preoperative radiotherapy does increase the risk for early complications due to unavoidable irradiation of the normal tissues surrounding the sarcoma mass, particularly for lower extremity lesions (6-9).
Preoperative radiotherapy aims to reduce tumor vitality prior to resection, theoretically allowing more conservative surgical therapy. Postoperative RT allows histological examination of the tumor specimen, especially the margins, aiding in further treatment planning; it may also be associated with fewer early wound complications. (10, 11).
In preoperative radiotherapy, as compared to postoperative radiotherapy, lower doses (50 versus 60 to 66 Gy) and smaller field sizes can be used, resulting in a reduced risk of late, often irreversible, complications. Consequently, preoperative RT is the preferred approach in many centers. Although the outcomes of combined RT and surgery are favorable, approximately 15% of the patients may relapse locally and about 30-50% distantly (dependent upon, among others, age, histopathology, size and grade), stressing the need for further improvement. These improvements should not only be sought in the domain of oncological endpoints, but also in decreasing treatment burden. A reduction in treatment duration, maintaining local control rates without increasing the rates of postoperative wound complications would serve the latter endpoints. For this purpose, quality of life questionnaires as well as patient reported outcomes measurements could come of help.Modern radiobiological investigations suggest that, on average, intermediate to high-grade soft tissue sarcomas may have α/β ratio's substantially below 10 Gy, justifying clinical studies exploring the possibility of (modest) hypofractionation. Obviously, various subtype derived cell lines exhibit different characteristics but on average an α/β ratio of 5 Gy would be a reasonable denominator for sarcomas as a group. However, it is important not to exaggerate hypofractionation in a setting where patients still need to undergo surgery.
- Conditions
- Soft Tissue Sarcomas
- Being tested
- pre-operative radiotherapy
- Keywords
- preoperative radiotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-operative radiotherapyRadiation
Also called radiotherapy
pre-operative radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 25x2Gy | Active comparator | the conventional schedule of 25 x 2 Gy, once daily fractionation in a five-week OTT Receives: Radiation: pre-operative radiotherapy |
| 14x3Gy | Experimental | the study schedule of 14 x 3 Gy, once daily fractionation in a three-week overall treatment time Receives: Radiation: pre-operative 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: 30 days post operative
Secondary outcomes (3)
local control
percentage of patients without local failure after surgery
Measured: During follow up (10 years)
long-term toxicity
fibrosis, edema, joint impairment and bone fractures
Measured: During follow up (10 years)
Wound complication rate
the rate of postoperative wound complications between day 31 and day 120 after surgery
Measured: From surgery until 120 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start25 Jun 2021
- Primary completion13 May 2026
- Study completion1 May 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomasStudies 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 the standard arm A of 50 Gy in 5 weeks or arm B with hypofractination of 14x3Gy
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Rick Haas, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425967
- Sponsor's protocol ID
- M20SCP
- Acronym
- SCOPES
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 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 Randomized Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04425967
- Acronym / sponsor ID
- SCOPES / M20SCP
- Conditions
- Soft Tissue Sarcomas
- Keywords
- preoperative radiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 168 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 1 May 2036 (estimated)
- First posted
- 11 Jun 2020 (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.
Currently, soft tissue sarcomas (STS) are preoperatively irradiated in a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Recent radiobiological investigations, however, suggest sensitivity to (modest) hypofractionation. Within this study, patients will be randomized to receive either the conventional schedule of 25 x 2 Gy or a shorter preoperative regimen of 14 x 3 Gy, in the hypothesis that both the postoperative wound complication rate until 30 days after surgery, as well as the local control probability at two years are comparable in both arms.
Detailed description
Surgery is the cornerstone in the treatment of non-metastatic sarcomas. Whenever feasible the resection should include a free surgical margin providing a rim of uninvolved tissue surrounding the tumor. In most deep located tumors however, to preserve essential neurovascular and bone structures and thus to preserve function, the margins are often limited. High grade tumors are, even with wider margins, at higher risk of local failure. Radiotherapy can reduce this risk of local failure.
Preoperative radiotherapy does increase the risk for early complications due to unavoidable irradiation of the normal tissues surrounding the sarcoma mass, particularly for lower extremity lesions (6-9).
Preoperative radiotherapy aims to reduce tumor vitality prior to resection, theoretically allowing more conservative surgical therapy. Postoperative RT allows histological examination of the tumor specimen, especially the margins, aiding in further treatment planning; it may also be associated with fewer early wound complications. (10, 11).
In preoperative radiotherapy, as compared to postoperative radiotherapy, lower doses (50 versus 60 to 66 Gy) and smaller field sizes can be used, resulting in a reduced risk of late, often irreversible, complications. Consequently, preoperative RT is the preferred approach in many centers. Although the outcomes of combined RT and surgery are favorable, approximately 15% of the patients may relapse locally and about 30-50% distantly (dependent upon, among others, age, histopathology, size and grade), stressing the need for further improvement. These improvements should not only be sought in the domain of oncological endpoints, but also in decreasing treatment burden. A reduction in treatment duration, maintaining local control rates without increasing the rates of postoperative wound complications would serve the latter endpoints. For this purpose, quality of life questionnaires as well as patient reported outcomes measurements could come of help.Modern radiobiological investigations suggest that, on average, intermediate to high-grade soft tissue sarcomas may have α/β ratio's substantially below 10 Gy, justifying clinical studies exploring the possibility of (modest) hypofractionation. Obviously, various subtype derived cell lines exhibit different characteristics but on average an α/β ratio of 5 Gy would be a reasonable denominator for sarcomas as a group. However, it is important not to exaggerate hypofractionation in a setting where patients still need to undergo surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomization between the standard arm A of 50 Gy in 5 weeks or arm B with hypofractination of 14x3Gy
| Arm | Type | Receives |
|---|---|---|
| 25x2Gy | Active comparator | Radiation: pre-operative radiotherapythe conventional schedule of 25 x 2 Gy, once daily fractionation in a five-week OTT |
| 14x3Gy | Experimental | Radiation: pre-operative radiotherapythe study schedule of 14 x 3 Gy, once daily fractionation in a three-week overall treatment time |
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 newly diagnosed intermediate to high grade soft tissue sarcoma localized to the extremities, trunk and chest wall or the head and neck area, 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 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. Patients with an uncertain metastatic status (e.g. small indifferent lung nodules) and patients with a low metastatic burden not precluding the application of both preoperative radiotherapy and definitive surgery, are allowed to participate;
- WHO Performance Status ≤ 2;
- Able and willing to undergo preoperative radiotherapy;
- Able and willing to undergo definitive surgery;
Key exclusion criteria (7 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 recurrent sarcomas who underwent prior radiotherapy to the target lesion (if the primary sarcoma was managed by surgery only and no perioperative RT, patients are eligible);
- Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas;
- 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;
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 |
|---|---|---|
| pre-operative radiotherapyAlso: radiotherapypre-operative radiotherapy | Radiation | 14x3Gy, 25x2Gy |
Primary outcome
the short-term toxicity
Time frame: 30 days post operative
wound complications
3 secondary outcomes
local control
Time frame: During follow up (10 years)
long-term toxicity
Time frame: During follow up (10 years)
Wound complication rate
Time frame: From surgery until 120 days post-surgery
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 17 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rick Haas, MD, PhD principal investigator
The Netherlands Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-operative radiotherapy in people with Soft Tissue Sarcomas, run by The Netherlands Cancer Institute at 4 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 7 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the short-term toxicity (time frame: 30 days post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.