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

Phase 2

• Conditions: cancer; squamous cell carcinoma of the larynx- and hypopharynx; 10027656; 10019190

• Registration Number: NL-OMON54203
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 27

Inclusion Criteria

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

Exclusion Criteria

- History of a clinically significant allergy or anaphylactic reactions to any
of the components of the agent;
- Other synchronous biopsy proven malignancies currently active, except for
adequately treated in situ carcinomaof cervix and basal or squamous cell skin
carcinoma;
- Patients pregnant or breastfeeding, lack of effective contraception in male
or female patients with reproductivepotential;
- Patients with renal insufficiency (defined as eGFR<60);
- Patients with previous kidney transplantation or a solitary functioning kidney
- 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;
- 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;
- Patients with ASA classification of 4 or higher;
- Patients with measured QTc of 500 ms or higher at screening;
- Patients with laboratory abnormalities defined as:
o Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl
Transferase) or AlkalinePhosphatase levels above 5 times the ULN or;
o Total bilirubin above 3 times the ULN or;
o Platelet count below 100 x 109/L or;
o Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males).
- Incapacitated subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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