Olfactory Neuroblastoma
Conditions
Keywords
Induction Chemotherapy
Brief 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. Participants will be treated with different chemotherapy schemes, to evaluate the tumor remission rate and long term survival.
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.
Interventions
DRUGGemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP)
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.
Sponsors
Hongmeng Yu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
umbrella design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with pathologically confirmed olfactory neuroblastoma; 2. Age ≥ 18 years old; 3. Dulguerov stage T2-T4; 4. Patients who signed the informed consent forms; 5. No distant metastasis.
Exclusion criteria
1. Patients with uncontrolled concurrent diseases that the researchers believe will interfere with treatment; 2. Any situation in which the patient may interfere with the compliance or safety during the study; 3. Severe neurological or mental illness, including dementia and seizures; 4. Uncontrolled active infection; 5. Pregnant or lactating women; 6. Persons without personal freedom and independent capacity for civil conduct; 7. Other situations that are not suitable for joining the group.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective remission rate(ORR) | 3 to 12 weeks after completion of induction chemotherapy | According to RECIST1.1 criteria, complete remission (CR) and partial remission (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete remission(pCR) rate after induction chemotherapy. | 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. |
| The rate of surgical pathology negative margin | 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. |
| 2-year overall survival (OS) rate | 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. |
| Rate of treatment related side effects | 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. |
Countries
China
Contacts
Primary ContactXiaole Song, MD
Backup ContactJingyi Yang, MD
Outcome results
None listed