NCT02910895 A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)
| NCT ID | NCT02910895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Netherlands Cancer Institute |
| Condition | Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2017-09-09 |
| Primary Completion | 2024-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2017-09-09 with a primary completion date of 2024-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Outside the setting of well-designed prospective clinical studies, the current standard preoperative RT should be a conventionally 1.8-2 Gy fractionated regimen to a total dose of 50 Gy in 5-6 weeks. However, given the vast diversity of sarcoma subtypes, it is also unlikely to assume a uniform therapeutic management to be optimal for all sarcomas alike. Other than 2 Gy fraction sizes and/or 50 Gy total dose series have been investigated in the past and should be further exploited in the future, but the practical implementation in humans is hampered by the rarity of the disease. The current systemic treatment of sarcomas consists of both the older cytotoxic chemotherapies and the newer targeted therapies like tyrosine kinase inhibitors. But it is hard to predict which patients will respond to which specific systemic treatment. This leads to worse prognoses and unnecessary toxicity for sarcoma patients. Despite the fact that the number of sarcoma patients in current studies is too small with a mix of different subtypes, some subtypes show a better response than other subtypes. This platform may form the basis for preclinical translational investigations with radiotherapy and various systemic treatments.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed diagnosed (non-) metastatic intermediate to high grade STS * Local recurrences are allowed * Age ≥ 18 years * Able and willing to undergo tumour biopsies or tumour sampling during surgery * Localization of sarcoma enables safe biopsy or surgery * Written informed consent Exclusion Criteria: * Known coagulation disorder and/or anticoagulant medication in as far it might interfere with a safe biopsy procedure (to the discretion of the treating physician and attending radiologist) * 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 study
Contact & Investigator
Rick Haas, MD, PhD
PRINCIPAL INVESTIGATOR
The Netherlands Cancer Institute
Frequently Asked Questions
Who can join the NCT02910895 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft Tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02910895 currently recruiting?
Yes, NCT02910895 is actively recruiting participants. Contact the research team at r.haas@nki.nl for enrollment information.
Where is the NCT02910895 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT02910895 clinical trial?
NCT02910895 is sponsored by The Netherlands Cancer Institute. The principal investigator is Rick Haas, MD, PhD at The Netherlands Cancer Institute. The trial plans to enroll 40 participants.