Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Neuroblastoma

Esthesioneuroblastoma, Olfactory

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Olfactory Nerve Diseases

Cranial Nerve Diseases

Olfactory Neuroblastoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Etoposide

Gemcitabine

Cyclophosphamide

Cisplatin

Etoposide phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Enzyme Inhibitors

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;

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.

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

Xiaole Song, MD

Jingyi Yang, MD

Hongmeng Yu, Dr

Xiaole Song, Dr

Xicai Sun, Dr

Jingyi Yang, Dr

Fu Chen, Dr

Hongmeng Yu, Prof.

Xicai Sun, MD

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.

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.

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

Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma: a Prospective Umbrella Clinical Study

Study Protocol, Informed Consent Form (ICF), Clinical Study Report (CSR) and Analytic Code were to be shared on request.

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

pCR rate refers to the probability that no tumor cells was found during pathological diagnosis of tumor sample of surgical treatment after induction chemotherapy, in all patients who have been enrolled in the group.

During the surgery after induction chemotherapy, 4-6 surgical margins were retrieved for each patient. The rate of surgical pathology negative margin refers to the probability that pathological examination showed no tumor cells in all surgical margins, among all patients who have been enrolled in the group.

The 2-year OS rate refers to the proportion of alive patients 2 years after enrollment, analyzed using the Kaplan Meier method.

Refers to the incident rate of side effects related to the prescribed treatment during the induction chemotherapy and the whole follow-up duration. Treatment-related side effects were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Hongmeng Yu

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma (ESICON)	NCT06255210	Olfactory Neuro...	Gemcitabine+Cis...	18 Years -	Eye & ENT Hospital of Fudan University
Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma (ESICON)	NCT06255210	Olfactory Neuro...	Gemcitabine+Cis...	18 Years -	Eye & ENT Hospital of Fudan University

Spots Global Cancer Trial Database for gemcitabine+cisplatin(gp); cyclophosphamide+etoposide+cisplatin(cep)