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

Last updated: February 4, 2024
Sponsor: Hongmeng Yu
Overall Status: Active - Recruiting

Phase

2

Condition

Neuroblastoma

Treatment

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

Clinical Study ID

NCT06255210
ONB-NACT-V1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Patients with uncontrolled concurrent diseases that the researchers believe willinterfere with treatment;
  2. Any situation in which the patient may interfere with the compliance or safety duringthe 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

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP)
Phase: 2
Study Start date:
March 01, 2024
Estimated Completion Date:
March 01, 2030

Study 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.

Connect with a study center

  • Eye & ENT Hospital of Fudan University

    Shanghai, Shanghai 200031
    China

    Active - Recruiting

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