Clinical trial · Interventional
Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma (ESICON)
Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma: a Prospective Umbrella Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Olfactory Neuroblastoma | Olfactory Neuroblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction chemotherapy in different subtypes of olfactory neuroblastoma
- description
- Induction chemotherapy based on pathological molecular subtypes of olfactory neuroblastoma. ① According to the immunohistochemical results of the pathological report, patients with Ki-67 index ≥ 25% were treated with two weeks of gemcitabine+platinum based chemotherapy regimen; ② According to the immunohistochemical results of the pathological report, patients with Ki-67 index \<25% were treated with a basic chemotherapy regimen of cyclophosphamide+etoposide+cisplatin (CEP regimen); According to the progression of the patient's disease, the combination of other chemotherapy/small molecule drugs/targeted drugs can be considered;
- interventionNames
- Drug: Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP)
Primary outcomes (1)
- measure
- Objective remission rate(ORR)
- timeFrame
- 3 to 12 weeks after completion of induction chemotherapy
- description
- According to RECIST1.1 criteria, complete remission (CR) and partial remission (PR)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDSvane-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
- BACKGROUNDWinters R, Das JM. Esthesioneuroblastoma. 2026 Jul 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK539694/ PMID 30969516
- BACKGROUNDKim 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
- BACKGROUNDDulguerov 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
- BACKGROUNDClasse 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