The STELLAR trial: Fluorescence-guided surgery in laryngeal- and hypopharyngeal cancer: a feasibility trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

31 Mar 2026 → ongoing

Decision date (initial)

2024-12-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-519750-36-00

EudraCT number

2020-003474-45

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Safety

The primary aim of this study is to determine the feasibility of using intraoperative fluorescence-imaging (FLI) to identify laryngeal and
hypopharyngeal cancer during total laryng(opharyng-)ectomy. A tumor-to-Background ratio (TBR) of >1.5 is defined as 'feasible'.

Secondary objectives 5

1. Sensitivity, specificity and positive predictive value of FLI
2. The intraoperative change in surgical management based on FLI
3. FLI of excised cervical lymph nodes
4. Influence of previous radiotherapy on the FLI performance
5. Adverse events and toxicity after intravenous injection with cRGD-ZW800- 1

Conditions and MedDRA coding

Squamous cell carcinoma of the larynx and hypopharynx

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients with biopsy-proven squamous cell LHC, eligible for surgical resection of the tumor by TL(P)
2. ≥ 18 years of age
3. Written informed consent must be obtained
4. Sufficient knowledge of the Dutch language to understand the informed consent form

Exclusion criteria 11

1. History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent
2. Patients with laboratory abnormalities defined as: Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or AlkalinePhosphatase levels above 5 times the ULN or; Total bilirubin above 3 times the ULN or; Platelet count below 100 x 109/L or; Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males)
3. Incapacitated subjects
4. Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinoma of cervix and basal or squamous cell skin carcinoma
5. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential
6. Patients with renal insufficiency (defined as eGFR<60)
7. Patients with previous kidney transplantation or a solitary functioning kidney
8. Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impairedor weakened immune system, caused by either a pre-existing disease or concomitant medications
9. Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX- 2inhibitors), that cannot be paused during the course of the study
10. Patients with ASA classification of 4 or higher
11. Patients with measured QTc of 500 ms or higher at screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary study endpoint of WP-1 is the tumor-to-background ratio (TBR) of laryngeal or pharyngeal tumours with fluorescence imaging after cRGD-ZW800-1 administration. The primary endpoint of WP-II is the number of clear resection margins

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Principal Investigator

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Principal Investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications