Clinical trial · Interventional
Single Arm Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced SNMM
A Prospective Single Arm Clinical Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced Sinonasal Malignant Melanoma
- 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)
Sinonasal mucosal melanoma (SNMM) is a very rare tumor, and SNMM is highly aggressive in nature, with a 5-year survival rate of about 20\~30%. Most patients underwent local recurrence and distant metastasis within one or two years of treatment. There is no unified standard for the treatment of SNMM.The principle of treatment for surgically resectable stage T3 and partial T4 SNMM is complete resection of the primary tumor, combined with postoperative radiotherapy. While locally unresectable SNMM has a poorer prognosis, lower incidence, fewer clinical data have been reported. This study will explore the role of preoperative radiotherapy and chemotherapy in improving the 2-year OS rate, loco-regional control rate and distant metastasis rate.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucosal Melanoma | Mucosal Melanoma | ONTOLOGY_EXACT | 0.98 |
| Sinonasal Melanoma | Sinonasal Mucosal Melanoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy drug | Drug | — | UNRESOLVED |
| endoscopic surgery | Procedure | — | UNRESOLVED |
| intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preoperative radiotherapy and chemotherapy
- description
- Preoperative radiotherapy and chemotherapy plus endoscopic surgery
- interventionNames
- Procedure: endoscopic surgery
- Radiation: intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy
- Drug: Chemotherapy drug
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From date of first treatment until the date of death from any cause,through study completion,up to 2 years.
- description
- 2 year Overall Survival rate
Secondary outcomes (5)
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age over 18 years old; 2. Pathologically confirmed with sinonasal mucosal melanoma; 3. Eligible for assessment by enhanced contrast computed tomography scan or magnetic Resonance Imaging (MRI); 4. T4N0-1M0 according to the 8th edition American Joint Committee on Cancer (AJCC) staging system, and breaks through the natural anatomical boundaries of orbital fascia or dura mater; or 2) any Tumor stage, with retropharyngeal node metastasis. unresectable tumor after multi-disciplinary team (MDT) discussion. 5. Eastern Cooperative Oncology Group (ECOG) score between 0 to 2; 6. No distant metastasis; 7. Adequate organ function; 8. Sign the informed consent forms. Exclusion Criteria: 1. There is evidence or suspicious of distant metastasis on clinical examination or imaging examination; 2. suffered from uncontrolled concurrent diseases that may interfere with treatment; 3. Suffered 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.); 4. With surgical contraindications: severe cardiopulmonary disease, coagulation dysfunction, etc; 5. With and conditions that interfere with patient compliance or safety; 6. With severe mental or neurological diseases; 7. Uncontrolled active infection diseases; 8. Pregnant or breastfeeding women; 9. Patients without personal freedom or independent civil capacity; 10. Other situations that are not suitable.
References
Publications (0)
Data not yet available