Clinical trial NCT06255210: Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma (ESICON)
Official title: Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma: a Prospective Umbrella Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Olfactory Neuroblastoma
Keywords: Induction Chemotherapy
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: umbrella design
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about the induction chemotherapy efficacy in olfactory neuroblastoma. The main question it aims to answer is: wether olfactory neuroblastoma patients with different pathology subtypes apply to different induction chemotherapy schemes. Participants will be treated with different chemotherapy schemes, to evaluate the tumor remission rate and long term survival.

Detailed description: This study included patients with olfactory neuroblastoma who were pathologically diagnosed and met the criteria. According to molecular profiles, two different induction chemotherapy schemes were used to evaluate the tumor remission rate.

Eligibility criteria: Inclusion Criteria:

1. Patients with pathologically confirmed olfactory neuroblastoma;
2. Age ≥ 18 years old;
3. Dulguerov stage T2-T4;
4. Patients who signed the informed consent forms;
5. No distant metastasis.

Exclusion Criteria:

1. Patients with uncontrolled concurrent diseases that the researchers believe will interfere with treatment;
2. Any situation in which the patient may interfere with the compliance or safety during the study;
3. Severe neurological or mental illness, including dementia and seizures;
4. Uncontrolled active infection;
5. Pregnant or lactating women;
6. Persons without personal freedom and independent capacity for civil conduct;
7. Other situations that are not suitable for joining the group.

Primary outcomes:
measure: Objective remission rate(ORR)
timeFrame: 3 to 12 weeks after completion of induction chemotherapy
Secondary outcomes:
measure: Pathological complete remission(pCR) rate after induction chemotherapy.
timeFrame: about 4 weeks after surgical resection, up to 12 weeks
measure: The rate of surgical pathology negative margin
timeFrame: about 4 weeks after surgical resection, up to 12 weeks
measure: 2-year overall survival (OS) rate
timeFrame: 2 years (24 months)
measure: Rate of treatment related side effects
timeFrame: 2 years (24 months)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital, Fudan University
name: Hongmeng Yu, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye & ENT Hospital, Fudan University
name: Xicai Sun, MD
role: STUDY_DIRECTOR
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citation: Limaiem F, Das JM. Esthesioneuroblastoma. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK539694/
citation: Kim N, Lee CG, Kim EH, Kim CH, Keum KC, Lee KS, Chang JH, Suh CO. Patterns of failures after surgical resection in olfactory neuroblastoma. J Neurooncol. 2019 Jan;141(2):459-466. doi: 10.1007/s11060-018-03056-0. Epub 2018 Nov 30.
citation: Dulguerov P, Allal AS, Calcaterra TC. Esthesioneuroblastoma: a meta-analysis and review. Lancet Oncol. 2001 Nov;2(11):683-90. doi: 10.1016/S1470-2045(01)00558-7.
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