Clinical trial NCT02910895: A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)
Official title: Development of a Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS): Protocol to Obtain Tumour Material From Patients With STS.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Soft Tissue Sarcoma
Xenograft Model
2D/3D Cell Cultures
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2016-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Primary outcomes:
measure: A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas
timeFrame: 4 months
measure: The take-rate of fresh human PDX tumour material in nude mice.
timeFrame: 4 months
measure: A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments)
timeFrame: 2 years after start of study
measure: A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.
timeFrame: 6 weeks
measure: A model for translational research
timeFrame: 2 years after start of study
Secondary outcomes:
measure: The passage possibilities of human PDX tumour material by freezing, storing, thawing and re-inoculating in nude mice
timeFrame: 4 months after implantation of tumour material
measure: Fractionation sensitivity on several STS subtypes in PDX.
timeFrame: 4 months
measure: To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing
timeFrame: 1 month
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
Study officials:
affiliation: The Netherlands Cancer Institute
name: Rick Haas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: