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Trial Title:
Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma (ESICON)
NCT ID:
NCT06255210
Condition:
Olfactory Neuroblastoma
Conditions: Official terms:
Neuroblastoma
Esthesioneuroblastoma, Olfactory
Cyclophosphamide
Cisplatin
Gemcitabine
Etoposide
Conditions: Keywords:
Induction Chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
umbrella design
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP)
Description:
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.
Arm group label:
Induction chemotherapy in different subtypes of olfactory neuroblastoma
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Eye & ENT Hospital of Fudan University
Address:
City:
Shanghai
Zip:
200031
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmeng Yu, Dr
Phone:
13501730576
Email:
hongmengyush@fudan.edu.cn
Contact backup:
Last name:
Xiaole Song, Dr
Phone:
15821388769
Email:
jxfxsxl@163.com
Investigator:
Last name:
Hongmeng Yu, Dr
Email:
Principal Investigator
Investigator:
Last name:
Xicai Sun, Dr
Email:
Sub-Investigator
Investigator:
Last name:
Xiaole Song, Dr
Email:
Sub-Investigator
Investigator:
Last name:
Jingyi Yang, Dr
Email:
Sub-Investigator
Investigator:
Last name:
Fu Chen, Dr
Email:
Sub-Investigator
Start date:
March 1, 2024
Completion date:
March 1, 2030
Lead sponsor:
Agency:
Hongmeng Yu
Agency class:
Other
Source:
Eye & ENT Hospital of Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06255210
