An interventional study of pre-operative radiotherapy in Soft Tissue Sarcomas, sponsored by The Netherlands Cancer Institute. Active, not recruiting at 4 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Treatment
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.
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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 168 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →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.
Able and willing to complete patient reported outcome questionnaires (health-related quality of life and cost effectiveness);
Exclusion Criteria:
the conventional schedule of 25 x 2 Gy, once daily fractionation in a five-week OTT
Radiation: pre-operative radiotherapy
the study schedule of 14 x 3 Gy, once daily fractionation in a three-week overall treatment time
Radiation: pre-operative radiotherapy
pre-operative radiotherapy
Also known as: radiotherapy
the short-term toxicity
wound complications
Time frame: 30 days post operative
local control
percentage of patients without local failure after surgery
Time frame: During follow up (10 years)
long-term toxicity
fibrosis, edema, joint impairment and bone fractures
Time frame: During follow up (10 years)
Wound complication rate
the rate of postoperative wound complications between day 31 and day 120 after surgery
Time frame: From surgery until 120 days post-surgery
Plan to share: No
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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The Netherlands Cancer Institute