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Olfactory NeuroblastomaPhase 2ESICONNCT06255210

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

A Phase 2 study testing Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP) in people with Olfactory Neuroblastoma, run by Hongmeng Yu at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Olfactory Neuroblastoma
What is being tested?
Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
1 Mar 2024to 1 Mar 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with pathologically confirmed olfactory neuroblastoma;
  • Age ≥ 18 years old;
  • Dulguerov stage T2-T4;
  • Patients who signed the informed consent forms;
  • No distant metastasis.

Who cannot join

  • Patients with uncontrolled concurrent diseases that the researchers believe will interfere with treatment;
  • Any situation in which the patient may interfere with the compliance or safety during the study;
  • Severe neurological or mental illness, including dementia and seizures;
  • Uncontrolled active infection;
  • Pregnant or lactating women;
  • Persons without personal freedom and independent capacity for civil conduct;
  • Other situations that are not suitable for joining the group.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaole Song, MD contact

15821388769

jxfxsxl@163.com

Jingyi Yang, MD contact

19529941927

yangjingyi_ent@163.com

China1 site, 1 recruiting

  • Eye & ENT Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200031

    Hongmeng Yu, Dr, 13501730576, hongmengyush@fudan.edu.cn

    Xiaole Song, Dr, 15821388769, jxfxsxl@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP)
Keywords
Induction Chemotherapy
Medical subject headings
Esthesioneuroblastoma, Olfactory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT06255210
Study groupRoleWhat they receive
Induction chemotherapy in different subtypes of olfactory neuroblastomaExperimentalInduction 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;
Receives: Drug: Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective remission rate(ORR)

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

    Measured: 3 to 12 weeks after completion of induction chemotherapy

Secondary outcomes (4)

  1. Pathological complete remission(pCR) rate after induction chemotherapy.

    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.

    Measured: about 4 weeks after surgical resection, up to 12 weeks

  2. The rate of surgical pathology negative margin

    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.

    Measured: about 4 weeks after surgical resection, up to 12 weeks

  3. 2-year overall survival (OS) rate

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

    Measured: 2 years (24 months)

  4. Rate of treatment related side effects

    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.

    Measured: 2 years (24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2024
  2. Study start1 Mar 2024 (estimated)
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
umbrella design
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06255210
Sponsor's protocol ID
ONB-NACT-V1
Acronym
ESICON
Status last verified
Feb 2024
First submitted
4 Feb 2024
Last updated
13 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study Protocol, Informed Consent Form (ICF), Clinical Study Report (CSR) and Analytic Code were to be shared on request.

Publications

  • Svane-Knudsen V, Jorgensen KE, Hansen O, Lindgren A, Marker P. Cancer of the nasal cavity and paranasal sinuses: a series of 115 patients. Rhinology. 1998 Mar;36(1):12-4.

    PubMed 9569435

  • Winters R, Das JM. Esthesioneuroblastoma. 2026 Jul 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK539694/

    PubMed 30969516

  • Kim N, Lee CG, Kim EH, Kim CH, Keum KC, Lee KS, Chang JH, Suh CO. Patterns of failures after surgical resection in olfactory neuroblastoma. J Neurooncol. 2019 Jan;141(2):459-466. doi: 10.1007/s11060-018-03056-0. Epub 2018 Nov 30.

    PubMed 30506150

  • Dulguerov P, Allal AS, Calcaterra TC. Esthesioneuroblastoma: a meta-analysis and review. Lancet Oncol. 2001 Nov;2(11):683-90. doi: 10.1016/S1470-2045(01)00558-7.

    PubMed 11902539

  • Classe M, Yao H, Mouawad R, Creighton CJ, Burgess A, Allanic F, Wassef M, Leroy X, Verillaud B, Mortuaire G, Bielle F, Le Tourneau C, Kurtz JE, Khayat D, Su X, Malouf GG. Integrated Multi-omic Analysis of Esthesioneuroblastomas Identifies Two Subgroups Linked to Cell Ontogeny. Cell Rep. 2018 Oct 16;25(3):811-821.e5. doi: 10.1016/j.celrep.2018.09.047.

    PubMed 30332658

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP) in people with Olfactory Neuroblastoma, run by Hongmeng Yu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaole Song, MD (15821388769, jxfxsxl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective remission rate(ORR) (time frame: 3 to 12 weeks after completion of induction chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06255210, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.

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