Studies

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Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas (SCOPES)

The SCOPES study: Towards reducing the treatment burden for soft tissue sarcoma patients

Period

06/25/2021 until 04/01/2034

Dutch title

Kortdurende pre-operatieve radiotherapie bij hoofd- en nek-, romp- en extremiteiten weke delen sarcomen

Acronym

SCOPES

Reference code

NCT04425967

Intervention model

Randomization between the standard arm A of 50 Gy in 5 weeks or arm B with hypofractination of 14x3Gy

Full description

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.

Inclusion criteria

For inclusion criteria, please click here to continue to the IKNL website

Exclusion criteria

For exclusion cirteria, please click here to continue to the IKNL website

Registration study on bone and soft tissue sarcoma

To prospectively and retrospectively collect data of patients with bone or soft tissue sarcoma in the Netherlands to improve the knowledge and therefore the treatment care.

Dutch title

Een lange termijn onderzoek naar de behandeling en uitkomsten van bot en weke delen sarcomen

Acronym

Registration study sarcoma

Reference code

NL69559.091.19

Intervention model

Observational study (observational cohort study)

Full Description

To prospectively and retrospectively collect data of patients with bone or soft tissue sarcoma in the Netherlands to improve the knowledge and therefore the treatment care. Besides to create a continuous basis for a large variety of research purposes including prognostic and predictive research, health care policies and cost-effectiveness studies.

Inclusion criteria

Age ≥ 18 years Histologically proven bone or soft tissue sarcoma, excluding Gastrointestinal Stromal Tumours

Exclusion criteria

Altered mental status that would prohibit the understanding of any giving of informed consent

Locations Netherlands

Radboudumc Radiotherapiegroep

Contact

Name: dr. P.M. Braam E-mail: p.braam@radboudumc.nl Phone: +31-243614515 Address: Radboudumc, Geert Grooteplein Zuid 32, 6525 GA Nijmegen

Documents:

Download Link	Size	Format
Proefpersoneninformatie	190 Kb	pdf
Studie Protocol	579 Kb	pdf