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

NCT02910895 | Recruiting

• 2 other identifiers: N16STSNL58626.031.16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Sarcoma; Xenograft Model; 2D/3D Cell Cultures

Outcome Measures

Primary Outcomes (5)

• A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas

  take rate

  4 months

• The take-rate of fresh human PDX tumour material in nude mice.

  take rate

  4 months

• A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments)

  take rate

  2 years after start of study

• A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.

  take rate

  6 weeks

• A model for translational research

  take rate

  2 years after start of study

Secondary Outcomes (3)

• 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

• Fractionation sensitivity on several STS subtypes in PDX.

  4 months

• To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing

  1 month

Study Arms (1)

single arm

OTHER

single tumor biopsy

Other: tumor biopsy

Interventions

tumor biopsy OTHER

biopsy

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• KU Leuven: collaborator

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Rick Haas, MD, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rick Haas, MD, PhD

CONTACT

+31 20 512 9111; r.haas@nki.nl

Astrid Scholten, MD, PhD

CONTACT

+31 20 512 9111; a.scholten@nki.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: September 22, 2016
• Study Start: September 9, 2017
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)