Mucosal MelanomaEarly Phase 1SNMMNCT05009446
Single Arm Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced SNMM
A Early Phase 1 study testing endoscopic surgery, intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy and Chemotherapy drug in people with Mucosal Melanoma and Sinonasal Melanoma, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucosal Melanoma, Sinonasal Melanoma
- What is being tested?
- endoscopic surgery, intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy and Chemotherapy drug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2021to 10 Aug 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Uncontrolled active infection diseases;
- Pregnant or breastfeeding women;
- Patients without personal freedom or independent civil capacity;
- Other situations that are not suitable.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye& ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
Weifang Wang, 13916229507
Xiaoshen Wang, MD,PhD
About this study
Official title: A Prospective Single Arm Clinical Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced Sinonasal Malignant Melanoma
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
- Being tested
- endoscopic surgery, intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy, Chemotherapy drug
- Keywords
- Sinonasal mucosal melanoma, Inductive radiotherapy, chemotherapy, overall survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic surgeryProcedure or surgery
endoscopic surgery or endoscope-assisted surgery open surgery
intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapyRadiation
radiotherapy was administrated before surgery
Chemotherapy drugDrug
Chemotherapy was administrated before surgery. Chemotherapy may also be administrated after surgery in selected cases.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative radiotherapy and chemotherapy | Experimental | Preoperative radiotherapy and chemotherapy plus endoscopic surgery Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
2 year Overall Survival rate
Measured: 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
the date of first treatment to the first recording of disease progression or death from any cause.
Measured: 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
the date of first treatment to local failure or death
Measured: 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
the date of first treatment to regional failure or death
Measured: 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
the date of first treatment to distant metastasis or death
Measured: From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years
ORR
objective remission rate
Measured: From date of first treatment to the date of best overall response before surgery, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start10 Aug 2021 (estimated)
- Primary completion10 Aug 2025 (estimated)
- Study completion10 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal MelanomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Principal investigator, Hongmeng Yu, Eye & ENT Hospital of Fudan University
- Investigators
- Hongmeng Yu, MD,PhD, Principal investigator, Eye& ENT Hospital of Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009446
- Sponsor's protocol ID
- SNMM-SA-RTNeo
- Acronym
- SNMM
- Status last verified
- Aug 2021
- First submitted
- 18 Jul 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Arm Clinical Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced Sinonasal Malignant Melanoma
- ClinicalTrials.gov ID
- NCT05009446
- Acronym / sponsor ID
- SNMM / SNMM-SA-RTNeo
- Conditions
- Mucosal Melanoma, Sinonasal Melanoma
- Keywords
- Sinonasal mucosal melanoma, Inductive radiotherapy, chemotherapy, overall survival
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 10 Aug 2021 (estimated)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 10 Aug 2025 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative radiotherapy and chemotherapy | Experimental | Procedure: endoscopic surgery, Radiation: intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy, Drug: Chemotherapy drugPreoperative radiotherapy and chemotherapy plus endoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic surgeryendoscopic surgery or endoscope-assisted surgery open surgery | Procedure or surgery | Preoperative radiotherapy and chemotherapy |
| intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapyradiotherapy was administrated before surgery | Radiation | Preoperative radiotherapy and chemotherapy |
| Chemotherapy drugChemotherapy was administrated before surgery. Chemotherapy may also be administrated after surgery in selected cases. | Drug | Preoperative radiotherapy and chemotherapy |
Primary outcome
Overall survival
Time frame: From date of first treatment until the date of death from any cause,through study completion,up to 2 years.
2 year Overall Survival rate
5 secondary outcomes
Progression-free survival
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years
ORR
Time frame: From date of first treatment to the date of best overall response before surgery, assessed up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongmeng Yu, MD,PhD principal investigator
Eye& ENT Hospital of Fudan University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing endoscopic surgery, intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy and Chemotherapy drug in people with Mucosal Melanoma and Sinonasal Melanoma, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaole Song, MD (15821388769, jxfxsxl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of first treatment until the date of death from any cause,through study completion,up to 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.