A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)

Not Applicable

Recruiting

• Conditions: Soft Tissue Sarcoma; Xenograft Model; 2D/3D Cell Cultures
• Interventions: Other: tumor biopsy

• Registration Number: NCT02910895
• Lead Sponsor: The Netherlands Cancer Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-22
• Study Start: 2017-09-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	tumor biopsy	single tumor biopsy

Primary Outcome Measures

Name	Time	Method
The take-rate of fresh human PDX tumour material in nude mice.	4 months	take rate
A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.	6 weeks	take rate
A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments)	2 years after start of study	take rate
A model for translational research	2 years after start of study	take rate
A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas	4 months	take rate

Secondary Outcome Measures

Name	Time	Method
The passage possibilities of human PDX tumour material by freezing, storing, thawing and re-inoculating in nude mice	4 months after implantation of tumour material	take rate of continuous growth of implantation of tumor material
To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing	1 month	take rate of continuous growth
Fractionation sensitivity on several STS subtypes in PDX.	4 months	take rate

Trial Locations

Locations (1)

Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands