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

Olfactory Neuroblastoma Clinical Trial

— ESICON  

Official title:

Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma: a Prospective Umbrella Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06255210
• Other study ID #: ONB-NACT-V1
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2024
• Est. completion date: March 1, 2030

Study information

• Verified date: February 2024
• Source: Eye & ENT Hospital of Fudan University
• Contact: Xiaole Song, MD
• Phone: 15821388769
• Email: jxfxsxl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 1, 2030
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esthesioneuroblastoma, Olfactory
• Neuroblastoma
• Olfactory Neuroblastoma

Intervention

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.

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hongmeng Yu

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Limaiem F, M Das J. Esthesioneuroblastoma. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK539694/ — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective remission rate(ORR)	According to RECIST1.1 criteria, complete remission (CR) and partial remission (PR)	3 to 12 weeks after completion of induction chemotherapy
Secondary	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.	about 4 weeks after surgical resection, up to 12 weeks
Secondary	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.	about 4 weeks after surgical resection, up to 12 weeks
Secondary	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.	2 years (24 months)
Secondary	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.	2 years (24 months)