Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06255210

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

Led by Hongmeng Yu · Updated on 2024-02-13

25

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of induction chemotherapy in patients with olfactory neuroblastoma, a rare type of cancer. The study aims to determine whether patients with different pathological subtypes benefit from different chemotherapy regimens. This prospective phase 2 clinical trial focuses on tumor remission rates and long-term survival outcomes based on molecular profiles of the tumor. Participants receive induction chemotherapy tailored to the molecular subtype of their tumor. Those with a Ki-67 index of 25% or higher are treated with a combination of gemcitabine and platinum-based drugs over two weeks. Patients with a Ki-67 index below 25% receive a different chemotherapy regimen consisting of cyclophosphamide, etoposide, and cisplatin. Additional drugs may be considered depending on disease progression. During the study, participants are monitored for tumor remission using objective remission rate measurements between 3 and 12 weeks after chemotherapy. Other assessments include pathological remission after surgery, surgical margin status, and treatment-related side effects over a two-year period. Overall survival is also tracked for two years to evaluate long-term outcomes. Participants will undergo regular follow-up visits to assess these outcomes and ensure safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with pathologically confirmed olfactory neuroblastoma
  • Age 18 years or older
  • Dulguerov stage T2 to T4
  • Patients who have signed informed consent forms
  • No distant metastasis
Not Eligible

You will not qualify if you...

  • Patients with uncontrolled concurrent diseases that may interfere with treatment
  • Any condition that could affect 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 deemed unsuitable for participation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks

Participants receive induction chemotherapy based on their tumor's molecular profile: those with a Ki-67 index ≥ 25% receive gemcitabine plus cisplatin, while those with a Ki-67 index < 25% receive cyclophosphamide, etoposide, and cisplatin. Treatment duration varies according to regimen and disease progression.

1 to 2 visits during chemotherapy

Post-treatment Surgical Evaluation

Duration - About 4 weeks up to 12 weeks

After induction chemotherapy, participants undergo surgical resection followed by pathological assessment to evaluate remission and surgical margin status.

1 visit (surgical and pathological evaluation)

Follow-up Monitoring

Duration - 2 years (24 months)

Participants are monitored for overall survival and treatment-related side effects for up to 2 years after treatment completion.

Periodic visits for safety and survival assessments

Trial Site Locations

Total: 1 location

1

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200031

Actively Recruiting

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Research Team

X

Xiaole Song, MD

J

Jingyi Yang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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