A Study to Evaluate the Value of Circulating Tumour DNA in Follow-up of Patients with an Advanced Gastroenteropancreatic or Lung Neuroendocrine Tumour Under Everolimus +- SSA Treatment

NCT05255133 | Completed

• 1 other identifier: Liquid-NET
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 8

Brief Summary

Prospective, multicentric, single arm, POC study to evaluate the value of CtDNA in follow-up of patients treated with everolimus, with or without somatostatin analogues for advanced gastroenteropancreatic or lung neuroendocrine tumours.

Conditions

Neuroendocrine Tumors

Keywords

Liquid biopsies

Outcome Measures

Primary Outcomes (1)

• Feasibility of treatment follow-up through CtDNA level measurement

  Feasibility of treatment follow-up through detection of a change in CtDNA levels before progression is apparent on imaging according to RECIST 1.1 and/or PERCIST 1.0 (if available) (Progression-free survival (PFS)).

  48 months

Secondary Outcomes (7)

• PFS under everolimus ± SSA treatment

  48 months

• Overall response rates under everolimus ± SSA treatment

  48 months

• Safety of everolimus ± SSA treatment according to the Common Terminology Criteria for Adverse Events 4 (CTCAE4) and in Belgium according to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  48 months

• Change in Quality of Life

  48 months

• Change in Quality of Life

  48 months

Study Arms (1)

GEP-NET and lung-NET patients

EXPERIMENTAL

Liquid biopsies and scans

Other: Liquid biopsies; Other: Scans (CT, gallium-68 DOTATE/TOC/NOC PET-CT)

Interventions

Liquid biopsies OTHER

Blood sampling will be done at regular intervals

GEP-NET and lung-NET patients

Scans (CT, gallium-68 DOTATE/TOC/NOC PET-CT) OTHER

Scans will be done at regular intervals

GEP-NET and lung-NET patients

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Written informed consent prior to any study-related procedure
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Histological proven diagnosis of a well or moderately differentiated GEP-NET (WHO2017 grade 1,2,3 neuroendocrine tumour)
• Documented progressive gastroenteropancreatic or lung neuroendocrine tumour by means of imaging and based upon the RECIST 1.1 criteria and/or PERCIST 1.0 criteria (if available) for which the treating physician has decided to treat with everolimus ± SSA treatment
• Presenting a positive CT and/or DOTANOC scan (at physician's discretion) at study entry with a measurable tumour lesion \> 1 cm (CT scan with a maximum slice thickness of 5 mm); baseline CT and/or DOTANOC scan performed up to 28 days prior start of treatment
• NO previous treatment with everolimus
• Adequate bone marrow and coagulation function as shown by:
• Haemoglobin ≥ 9.0 g/dL
• ANC ≥ 1,500/mm3 (≥1.5 x 109/L)
• Platelets ≥ 100,000/mm3 (≥ 100x 109/L)
• INR ≤ 2.0
• Adequate liver function as shown by:
• Alanine aminotransferase and aspartate aminotransferase ≤2.5xULN (Upper limit of normal) (or ≤ 5 if hepatic metastases are present)
• Total serum bilirubin ≤ 1.5 x ULN (≤ 3 ULN for patients known to have Gilbert Syndrome)

You may not qualify if:

• Patients with only non-measurable lesions by CT
• Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin) or other contra-indications for everolimus ± SSA treatment
• Unavailable archival tissue and patient unwilling to have a new biopsy
• Prior treatment with everolimus
• History of drug hypersensitivity with a similar chemical structure to lanreotide Autogel 120mg, sandostatin LAR or everolimus
• Unresolved Grade 3 or 4 toxicity from prior therapy, including experimental therapy
• History or clinical evidence of other malignancy within 3 years prior to enrolment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
• Major surgery within 4 weeks of first dose administration
• History of symptomatic brain metastases or other central nervous system metastases.
• Patients receiving concomitant immunosuppressive agents or chronic corticosteroid use at the time of study entry except in cases outlined below:
• Topical applications (e.g. rash)
• Inhaled sprays (e.g. obstructive airways disease)
• Eye drops
• Local injections (e.g. intra-articular)
• Stable low dose of corticosteroids for at least two weeks before enrolment

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Kom Op Tegen Kanker: collaborator
• University Hospital, Antwerp: collaborator

Study Sites (8)

GZA

Antwerp, Antwerp, 2610, Belgium

Location

AZ Rivierenland

Bornem, Antwerp, 2880, Belgium

Location

AZ Klina

Brasschaat, Antwerp, 2930, Belgium

Location

AZ Monica

Deurne, Antwerp, 2100, Belgium

Location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

AZ Voorkempen

Malle, Antwerp, 2390, Belgium

Location

ZNA

Merksem, Antwerp, 2170, Belgium

Location

AZ Nikolaas

Sint-Niklaas, East-Flanders, 9100, Belgium

Location

Related Publications (1)

• Boons G, Vandamme T, Marien L, Lybaert W, Roeyen G, Rondou T, Papadimitriou K, Janssens K, Op de Beeck B, Simoens M, Demey W, Dero I, Van Camp G, Peeters M, Op de Beeck K. Longitudinal Copy-Number Alteration Analysis in Plasma Cell-Free DNA of Neuroendocrine Neoplasms is a Novel Specific Biomarker for Diagnosis, Prognosis, and Follow-up. Clin Cancer Res. 2022 Jan 15;28(2):338-349. doi: 10.1158/1078-0432.CCR-21-2291. Epub 2021 Nov 10.

  PMID: 34759042 BACKGROUND

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: February 24, 2022
• Study Start: October 9, 2017
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (8)