A prospective single arm clinical study of induction chemoradiotherapy combined with surgery in the treatment of locally advanced sinonasal malignant melanoma

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100049031

Enrollment

Unknown

Registered

2021-07-20

Start date

2021-07-19

Completion date

Unknown

Last updated

2022-03-28

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

Conditions

sinonasal malignant melanoma

Interventions

Group 1:preoperative concurrent chemoradiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged > 18 years old; 2. Initially treated and pathologically diagnosed as malignant melanoma of the nasal cavity and paranasal sinuses; 3. Suitable for enhanced CT or MRI image evaluation; 4. According to the eighth edition of AJCC staging criteria: T4N0-1M0 breaks through the natural anatomical boundaries such as orbital fascia and dura mater, or regardless of T staging, it is accompanied by retropharyngeal lymph node metastasis. Those who are not easy to be surgically removed after multidisciplinary discussions; 5. ECOG score 0-2; 6. No distant metastasis; 7. Adequate organ function; 8. Sign the informed consent form before starting the study.

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled concurrent diseases that the investigator believes will interfere with treatment; 2. Suffering from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.); 3. The patient has any circumstances that may hinder the compliance of the protocol study or the safety during the study; 4. There are serious neurological or psychiatric diseases, including dementia and seizures; 5. Uncontrolled active infection; 6. Pregnant or breastfeeding women; 7. Those without personal freedom and independent civil capacity; 8. There are other situations that are not suitable for inclusion in the group.

Design outcomes

Primary

Measure	Time frame
2y-overall survival rate;	—

Secondary

Measure	Time frame
2y-progression free survival;regional progression free survival;distant metastasis-free survival;local progression free survival;	—

Countries

China

Contacts

Public ContactYu Hongmeng

Eye and Ear Nose and Throat Hospital Affiliated to Fudan University

hongmengyush@fudan.edu.cn+86 13501730576

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026