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Trial record 1 of 2 for:    Short Course Of Preoperative Radiotherapy in Extremity Soft Tissue Sarcomas | sarcoma
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Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas (SCOPES)

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ClinicalTrials.gov Identifier: NCT04425967
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : October 7, 2022
Leiden University Medical Center
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcomas Radiation: pre-operative radiotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a Randomized Phase II Clinical Trial
Actual Study Start Date : June 25, 2021
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2034

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 25x2Gy
the conventional schedule of 25 x 2 Gy, once daily fractionation in a five-week OTT
Radiation: pre-operative radiotherapy
pre-operative radiotherapy
Other Name: radiotherapy

Experimental: 14x3Gy
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
Other Name: radiotherapy

Primary Outcome Measures :
  1. the short-term toxicity [ Time Frame: 30 days post operative ]
    wound complications

Secondary Outcome Measures :
  1. local control [ Time Frame: 2 years ]
    percentage of patients without local failure after surgery

  2. long-term toxicity [ Time Frame: 2 years ]
    fibrosis, edema, joint impairment and bone fractures

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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;
  • 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 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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04425967

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Contact: Rick Haas, MD, PhD +31 20 512 9111 r.haas@nki.nl
Contact: Astrid Scholten, MD, PhD +31 20 512 9111 a.scholten@nki.nl

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Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9713GZ
Contact: Hans Langendijk, MD, PhD    +31 50 361 5532    j.a.langendijk@umcg.nl   
Leids Universitair Medisch Centrum Recruiting
Leiden, Netherlands, 2333ZA
Contact: Lisette M Wiltink, MD, PhD    (071) 526 91 11    l.m.wiltink@lumc.nl   
Contact: Stijn Krol, MD, PhD    (071) 526 91 11    a.d.g.krol@lumc.nl   
Radboudumc Not yet recruiting
Nijmegen, Netherlands, 6525GA
Contact: Petra Braam, MD,PhD    +31243614023    p.braam@radboudumc.nl   
Sponsors and Collaborators
The Netherlands Cancer Institute
Leiden University Medical Center
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Principal Investigator: Rick Haas, MD, PhD The Netherlands Cancer Institute
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT04425967    
Other Study ID Numbers: M20SCP
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: October 7, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
preoperative radiotherapy
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type