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

ConditionOlfactory Neuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHongmeng Yu

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients with pathologically confirmed olfactory neuroblastoma;

Age ≥ 18 years old;

Dulguerov stage T2-T4;

Patients who signed the informed consent forms;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Induction chemotherapy in different subtypes of olfactory neuroblastomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective remission rate(ORR)

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

Time frame
3 to 12 weeks after completion of induction chemotherapy

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
2 years (24 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hongmeng Yu

Lead sponsor

Eye & ENT Hospital of Fudan University

Sponsor institution

Source ClinicalTrials.gov
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