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NCT Number: NCT06255210

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

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.

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Key information

Conditions

Olfactory Neuroblastoma Cranial Nerve Diseases Esthesioneuroblastoma, Olfactory Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Olfactory Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location status: Recruiting

Location contact

Fu Chen, Dr

SUB_INVESTIGATOR

Hongmeng Yu, Dr

CONTACT

[email protected]

13501730576

Hongmeng Yu, Dr

PRINCIPAL_INVESTIGATOR

Jingyi Yang, Dr

SUB_INVESTIGATOR

Xiaole Song, Dr

CONTACT

[email protected]

15821388769

Xiaole Song, Dr

SUB_INVESTIGATOR

Xicai Sun, Dr

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jingyi Yang, MD

CONTACT

[email protected]

19529941927

Xiaole Song, MD

CONTACT

[email protected]

15821388769

Sponsors and collaborators

Lead sponsor

Hongmeng Yu

Other

Registry information

Official study title

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

Acronym: ESICON

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Feb 13, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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