Testing chemotherapy effectiveness for olfactory neuroblastoma
Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma: a Prospective Umbrella Clinical Study
This study is testing two different chemotherapy combinations to see which one works better for people with olfactory neuroblastoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06255210 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of different induction chemotherapy regimens in patients diagnosed with olfactory neuroblastoma. Participants will receive either Gemcitabine combined with Cisplatin or a regimen of Cyclophosphamide, Etoposide, and Cisplatin, based on their tumor's molecular profile. The study will assess tumor remission rates and long-term survival outcomes to determine the most effective treatment approach for various pathology subtypes of the disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with pathologically confirmed olfactory neuroblastoma at Dulguerov stages T2-T4.
Not a fit: Patients with uncontrolled concurrent diseases, severe neurological or mental illnesses, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with olfactory neuroblastoma, improving their chances of remission and survival.
How similar studies have performed: While there have been studies on chemotherapy for various cancers, this specific approach for olfactory neuroblastoma is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Eye & ENT Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Hongmeng Yu, Prof. — Eye & ENT Hospital, Fudan University
- Study coordinator: Xiaole Song, MD
- Email: jxfxsxl@163.com
- Phone: 15821388769
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.