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

February 4, 2024 updated by: Hongmeng Yu

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Recruiting
        • Eye & Ent Hospital of Fudan University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hongmeng Yu, Dr
        • Sub-Investigator:
          • Xicai Sun, Dr
        • Sub-Investigator:
          • Xiaole Song, Dr
        • Sub-Investigator:
          • Jingyi Yang, Dr
        • Sub-Investigator:
          • Fu Chen, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction chemotherapy in different subtypes of olfactory neuroblastoma

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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate(ORR)
Time Frame: 3 to 12 weeks after completion of induction chemotherapy
According to RECIST1.1 criteria, complete remission (CR) and partial remission (PR)
3 to 12 weeks after completion of induction chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete remission(pCR) rate after induction chemotherapy.
Time Frame: 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.
about 4 weeks after surgical resection, up to 12 weeks
The rate of surgical pathology negative margin
Time Frame: 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.
about 4 weeks after surgical resection, up to 12 weeks
2-year overall survival (OS) rate
Time Frame: 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.
2 years (24 months)
Rate of treatment related side effects
Time Frame: 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 years (24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hongmeng Yu

Investigators

  • Principal Investigator: Hongmeng Yu, Prof., Eye & ENT Hospital, Fudan University
  • Study Director: Xicai Sun, MD, Eye & ENT Hospital, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

February 4, 2024

First Submitted That Met QC Criteria

February 4, 2024

First Posted (Estimated)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONB-NACT-V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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