Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma (ESICON)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP).
- Who it may be relevant to
- Registry conditions: Olfactory Neuroblastoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma: a Prospective Umbrella Clinical Study
Overview
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
- Drug Gemcitabine+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.
Primary outcome measures
- Objective remission rate(ORR) [Time frame: 3 to 12 weeks after completion of induction chemotherapy]
Secondary outcome measures (4)
- Pathological complete remission(pCR) rate after induction chemotherapy. [Time frame: about 4 weeks after surgical resection, up to 12 weeks]
- The rate of surgical pathology negative margin [Time frame: about 4 weeks after surgical resection, up to 12 weeks]
- 2-year overall survival (OS) rate [Time frame: 2 years (24 months)]
- Rate of treatment related side effects [Time frame: 2 years (24 months)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Eye & ENT Hospital of Fudan University — Shanghai
Publications
- Svane-Knudsen V, Jorgensen KE, Hansen O, Lindgren A, Marker P. Cancer of the nasal cavity and paranasal sinuses: a series of 115 patients. Rhinology. 1998 Mar;36(1):12-4. PMID 9569435
- Limaiem F, Das JM. Esthesioneuroblastoma. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK539694/ PMID 30969516
- Kim N, Lee CG, Kim EH, Kim CH, Keum KC, Lee KS, Chang JH, Suh CO. Patterns of failures after surgical resection in olfactory neuroblastoma. J Neurooncol. 2019 Jan;141(2):459-466. doi: 10.1007/s11060-018-03056-0. Epub 2018 Nov 30. PMID 30506150
- Dulguerov P, Allal AS, Calcaterra TC. Esthesioneuroblastoma: a meta-analysis and review. Lancet Oncol. 2001 Nov;2(11):683-90. doi: 10.1016/S1470-2045(01)00558-7. PMID 11902539
- Classe M, Yao H, Mouawad R, Creighton CJ, Burgess A, Allanic F, Wassef M, Leroy X, Verillaud B, Mortuaire G, Bielle F, Le Tourneau C, Kurtz JE, Khayat D, Su X, Malouf GG. Integrated Multi-omic Analysis of Esthesioneuroblastomas Identifies Two Subgroups Linked to Cell Ontogeny. Cell Rep. 2018 Oct 16;25(3):811-821.e5. doi: 10.1016/j.celrep.2018.09.047. PMID 30332658
Identifiers
NCT: NCT06255210 · ONB-NACT-V1