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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGObjective 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
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
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
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)
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)
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