Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma (ESICON)

NCT06255210 | Recruiting Phase 2

• 1 other identifier: ONB-NACT-V1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Olfactory Neuroblastoma

Keywords

Induction Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Objective remission rate(ORR)

  According to RECIST1.1 criteria, complete remission (CR) and partial remission (PR)

  3 to 12 weeks after completion of induction chemotherapy

Secondary Outcomes (4)

• Pathological complete remission(pCR) rate after induction chemotherapy.

  about 4 weeks after surgical resection, up to 12 weeks

• The rate of surgical pathology negative margin

  about 4 weeks after surgical resection, up to 12 weeks

• 2-year overall survival (OS) rate

  2 years (24 months)

• Rate of treatment related side effects

  2 years (24 months)

Study Arms (1)

Induction chemotherapy in different subtypes of olfactory neuroblastoma

EXPERIMENTAL

Induction chemotherapy based on pathological molecular subtypes of olfactory neuroblastoma. ① According to the immunohistochemical results of the pathological report, patients with Ki-67 index ≥ 25% were treated with two weeks of gemcitabine+platinum based chemotherapy regimen; ② According to the immunohistochemical results of the pathological report, patients with Ki-67 index \<25% were treated with a basic chemotherapy regimen of cyclophosphamide+etoposide+cisplatin (CEP regimen); According to the progression of the patient's disease, the combination of other chemotherapy/small molecule drugs/targeted drugs can be considered;

Drug: Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP)

Interventions

Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP) DRUG

When the Ki67% index of the tumor is ≥ 25%, patients were treated with the GP regimen for induction chemotherapy; When the Ki67% index of the tumor is \< 25%, patients were treated with the CEP regimen for induction chemotherapy.

Induction chemotherapy in different subtypes of olfactory neuroblastoma

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hongmeng Yu: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Related Publications (5)

• Svane-Knudsen V, Jorgensen KE, Hansen O, Lindgren A, Marker P. Cancer of the nasal cavity and paranasal sinuses: a series of 115 patients. Rhinology. 1998 Mar;36(1):12-4.

  PMID: 9569435 BACKGROUND

• 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/

  PMID: 30969516 BACKGROUND

• 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.

  PMID: 30506150 BACKGROUND

• 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.

  PMID: 11902539 BACKGROUND

• Classe M, Yao H, Mouawad R, Creighton CJ, Burgess A, Allanic F, Wassef M, Leroy X, Verillaud B, Mortuaire G, Bielle F, Le Tourneau C, Kurtz JE, Khayat D, Su X, Malouf GG. Integrated Multi-omic Analysis of Esthesioneuroblastomas Identifies Two Subgroups Linked to Cell Ontogeny. Cell Rep. 2018 Oct 16;25(3):811-821.e5. doi: 10.1016/j.celrep.2018.09.047.

  PMID: 30332658 BACKGROUND

MeSH Terms

Conditions

Esthesioneuroblastoma, Olfactory

Condition Hierarchy (Ancestors)

Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Olfactory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Hongmeng Yu, Prof.

  Eye & ENT Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

• Xicai Sun, MD

  Eye & ENT Hospital, Fudan University

  STUDY DIRECTOR

Central Study Contacts

Xiaole Song, MD

CONTACT

15821388769; jxfxsxl@163.com

Jingyi Yang, MD

CONTACT

19529941927; yangjingyi_ent@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: umbrella design

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2030
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)