Single Arm Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced SNMM

NCT05009446 | Unknown Early Phase 1

• 1 other identifier: SNMM-SA-RTNeo
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Mucosal Melanoma; Sinonasal Melanoma

Keywords

Sinonasal mucosal melanoma; Inductive radiotherapy; chemotherapy; overall survival

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2 year Overall Survival rate

  From date of first treatment until the date of death from any cause,through study completion,up to 2 years.

Secondary Outcomes (5)

• Progression-free survival

  From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to2 years

• Local progression free survival

  From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years

• Regional progression free survival

  From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years

• Distant metastasis free survival

  From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years

• ORR

  From date of first treatment to the date of best overall response before surgery, assessed up to 6 months

Study Arms (1)

Preoperative radiotherapy and chemotherapy

EXPERIMENTAL

Preoperative radiotherapy and chemotherapy plus endoscopic surgery

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

Interventions

endoscopic surgery PROCEDURE

endoscopic surgery or endoscope-assisted surgery open surgery

Preoperative radiotherapy and chemotherapy

intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy RADIATION

radiotherapy was administrated before surgery

Preoperative radiotherapy and chemotherapy

Chemotherapy drug DRUG

Chemotherapy was administrated before surgery. Chemotherapy may also be administrated after surgery in selected cases.

Preoperative radiotherapy and chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years old;
• Pathologically confirmed with sinonasal mucosal melanoma;
• Eligible for assessment by enhanced contrast computed tomography scan or magnetic Resonance Imaging (MRI);
• 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.
• Eastern Cooperative Oncology Group (ECOG) score between 0 to 2;
• No distant metastasis;
• Adequate organ function;
• Sign the informed consent forms.

You may not qualify if:

• There is evidence or suspicious of distant metastasis on clinical examination or imaging examination;
• suffered from uncontrolled concurrent diseases that may interfere with treatment;
• 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.);
• With surgical contraindications: severe cardiopulmonary disease, coagulation dysfunction, etc;
• With and conditions that interfere with patient compliance or safety;
• With severe mental or neurological diseases;
• Uncontrolled active infection diseases;
• Pregnant or breastfeeding women;
• Patients without personal freedom or independent civil capacity;
• Other situations that are not suitable.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Interventions

Endoscopy; Radiotherapy, Intensity-Modulated; Protons; Heavy Ion Radiotherapy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Hongmeng Yu, MD,PhD

  Eye& ENT Hospital of Fudan University, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaole Song, MD

CONTACT

15821388769; jxfxsxl@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,Head of Rhinology

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: August 17, 2021
• Study Start: August 10, 2021
• Primary Completion: August 10, 2025
• Study Completion: August 10, 2025
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

CN (1)