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

Phase 2

Recruiting

• Conditions: Olfactory Neuroblastoma
• Interventions: Drug: Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP)

• Registration Number: NCT06255210
• Lead Sponsor: Hongmeng Yu

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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-04
• Study First Submitted QC: 2024-02-04
• Last Update Submitted: 2024-02-04
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13
• Study Start: 2024-03-01
• Primary Completion: 2027-03-01
• Study Completion: 2030-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Induction chemotherapy in different subtypes of olfactory neuroblastoma	Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP)	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;

Primary Outcome Measures

Name	Time	Method
Objective remission rate(ORR)	3 to 12 weeks after completion of induction chemotherapy	According to RECIST1.1 criteria, complete remission (CR) and partial remission (PR)

Secondary Outcome Measures

Name	Time	Method
Rate of treatment related side effects	2 years (24 months)	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.
2-year overall survival (OS) rate	2 years (24 months)	The 2-year OS rate refers to the proportion of alive patients 2 years after enrollment, analyzed using the Kaplan Meier method.
Pathological complete remission(pCR) rate after induction chemotherapy.	about 4 weeks after surgical resection, up to 12 weeks	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.
The rate of surgical pathology negative margin	about 4 weeks after surgical resection, up to 12 weeks	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.

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China