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Effectiveness of radiotherapy versus endoscopic surgery in the treatment of olfactory neuroblastoma sensitive to chemotherapy: A randomized controlled clinical trial

Effectiveness of radiotherapy versus endoscopic surgery in the treatment of olfactory neuroblastoma sensitive to chemotherapy: A randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024193
Enrollment
Unknown
Registered
2019-06-29
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

olfactory neuroblastoma

Interventions

1:endoscopic surgery+radiotherapy
2:radiotherapy+/- endoscopic surgery

Sponsors

Eye, Ear, Nose, and Throat Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Sign of inform consent; 2. Age 18~70 years; 3. Pathological evidence of olfactory neuroblastoma; 4. Sensitive to chemotherapy: >=50% partial remission after chemotherapy; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 6. Without metastasis; 7. General physical condition compatible with the proposed radiotherapy and surgery; Surgically resectable; 8. Acceptable organ function; 9. Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated.

Exclusion criteria

Exclusion criteria: 1. Patients with evidence of distant metastases or leptomeningeal disease (LMD); 2. Patients received previous irradiation for head and neck tumor, skull base, or brain tumors; 3. Previous history of surgery or radiotherapy for current disease; 4. Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy; 5. Patients with a history of a different malignancy are excluded, unless the disease has not progressed for >= 2 years; 6. Contraindication for surgery; 7. Patients may have any co-existing condition that would preclude full compliance with the study; 8. Severe neuropathy or psychiatric disorders, including dementia and seizures; 9. Infectious disease out of control; 10. Women pregnant or breast-feeding.

Design outcomes

Primary

MeasureTime frame
overall survival rate;Overall survival;

Secondary

MeasureTime frame
life quality;Locoregional recurrence Free Suvival;

Countries

China

Contacts

Public ContactXicai Sun

Eye, Ear, Nose, and Throat Hospital, Fudan University

laryngeal@163.com+86 15821388769

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026