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Studies - Dutch Sarcoma Group
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The value of a risk prediction tool (PERSARC) for effective treatment decisions of soft tissue sarcomas patients.

To investigate the value of a risk prediction tool (PERSARC) for effective treatment decisions of soft tissue sarcomas patients.

Period

08/01/2021 until 08/31/2024

Dutch title

De waarde van een risicovoorspellingstool (PERSARC) voor effectieve behandelbeslissingen voor patiënten met wekedelen sarcomen.

Acronym

VALUE-PERSARC

Reference code

NL76563.058.21

Intervention model

High-grade extremity STS patients will either receive standard care (control group) or care with the use of PERSARC; i.e. PERSARC will be used in multidisciplinary tumour boards to guide treatment advice and in consultation in which the oncological/orthopaedic surgeon informs the patient about his/her diagnoses and discusses the benefits and harms of all relevant treatment options (intervention group).

Full description

Currently, there is no consensus about the optimal treatment for patients with high grade soft tissue sarcomas (STS) which are localized in the extremities. To ensure overall survival, there is a tendency to operate with wide resection margins, but this has a high impact on quality of life especially when limb function must be sacrificed. (Neo)adjuvant radiotherapy allows for narrower surgical margins but is associated with significant short -and long-term side-effects. As evidence on the best treatment is lacking, treatment choice for individual patients should be driven by their weighing of the benefits and harms of the treatment options in light of their personal situation. However, current treatment decision-making in STS care is one-size fits all, and not informed by individualized risks of treatment options and patients’ preferences. Consequently, there is no guarantee that patients with STS will receive treatment that is appropriate for their situation, and patients experience uncertainty about which treatment is best for their personal situation (decisional conflict). From literature it is known that decision supporting interventions contribute to a better informed choice and less decisional conflict. Therefore, our research group developed a validated personalized risk assessment tool (Personalised Sarcoma Care: PERSARC) which provides patients and STS professionals insight into the personalized risks and benefits of each treatment option based on patient’s age, tumor size, tumor depth and histology in their decision-making process. It is hypothesized that use of PERSARC leads to significantly less decisional conflict in patients and more informed decisions compared to usual care (treatment decisions without use of PERSARC) by reducing the uncertainty regarding risks and benefits of treatment options in high-grade extremity STS patients.

Inclusion criteria

Patients (>= 18 years) with primarily diagnosed (histologically confirmed) grade 2-3 extremity STS, who do not have a treatment plan yet and will be treated with curative intent. Patients with sarcoma subtypes or treatment options other than those mentioned in the PERSARC app are unable to participate. Furthermore, patients need to be Dutch fluency and literacy and mentally competent.

Exclusion criteria

Patient that are treated without curative intent Patient that needs to be treated with chemotherapy or isolated limb perfusion Patients were surgery is not indicated Sarcoma subtypes not mentioned in the PERSARC app

Contact

Name: Anouk Kruiswijk Email: a.a.kruiswijk@lumc.nl Phone: 0631974532

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:

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