Back to resultsMucosal Melanoma of Head and Neck in Intensity-modulated Radiotherapy Era
Primary Purpose
Mucosal Melanoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
RT
Sponsored by
About this trial
This is an interventional treatment trial for Mucosal Melanoma focused on measuring mucosal melanoma, radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically confirmed mucosal melanoma of head and neck (MMHN);
- Tumor staged as stages III/IVA (according to the American Joint Committee on Cancer 7th edition staging system) arising from head and neck according to the radiology and clinical exam;
- Prior local resection to primary tumor;
- Radiologically confirmed (MRI, CT or PET-CT if necessary) no regional lymph node present, nor any evidence of distant metastasis;
- Adequate marrow: white blood cell count of 4.0 × 109/L or more; absolute neutrophil of 2.0 × 109/L or more; haemoglobin concentrations of at least 90 g/L; platelet cell count of 100 × 109/L or more；
- Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2.5×upper limit of normal (ULN)；
- Adequate renal function: creatinine clearance rate of more than 60 mL/min;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
- Expected lifespan > 3 months;
- Patients must be informed of the investigational nature of this study and give written informed consent；
- Patients must be consent to the follow-up till death, the study termination or the end of the study.
Exclusion Criteria:
- Patients with histologically or radiologically distant metastasis or recurrence of primary tumor;
- Any contraception to RT;
- History of previous RT or chemotherapy;
- Any severe previous or intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, serious comorbidities, or had active lupus erythematosus or scleroderma, unstable cardiac disease needing treatment, chronic obstructive pulmonary disease exacerbation or other respiratory illness needing treatment, or an acute or fungal infection requiring treatmen);
- Prior malignancy within 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer;
- Pregnancy or lactation;
- Unable or unwilling to the compliance of the study
Sites / Locations
- LiXia LuRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RT
Arm Description
The patients are prescribed a EQD2of 65-70Gy to CTV1(high-risk regions including tumor bed), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT). The Prophylactic irradiation to upper neck is is decided by radiation physicians and given a EQD2 of 70-77Gy to CTVnd (clinically negative lymph nodes), 50-55Gy to CTVn2（neck nodal regions). If there is residual tumor, a EQD2 of 70-77Gy is prescribed to GTV.
Outcomes
Primary Outcome Measures
Overall survival(OS)
OS is calculated from the first day of therapy to the day of death, or to the last follow-up.
Secondary Outcome Measures
Regional relapse-free survival(RRFS)
RFS is calculated from the first day of therapy to regional failure from any cause. Regional relapses were diagnosed with clinical examination of the neck and, in doubtful cases, by fine needle aspiration or an MRI scan of the neck.
Local recurrence-free survival(LRFS)
the first day of therapy to local failure from any cause. Local relapses were diagnosed by fibreoptic endoscopy and biopsy.
Distant metastasis-free survival (DMFS)
DMFS is calculated from the first day of treatment to the date of first remote. Distant metastases were diagnosed by clinical symptoms, physical examinations, and imaging methods that included CT, MRI, bone scan, abdominal sonography, and/or PET-CT.
Number of participants with adverse events
Number of participants with acute and late toxicity and treatment-related mortality.Adverse events were recorded according to the Common Terminology Criteria for Adverse Events (version 4.0) at each treatment visit, follow-up visit, and at the end of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03138642
Brief Title
Mucosal Melanoma of Head and Neck in Intensity-modulated Radiotherapy Era
Official Title
A Prospective Phase II Study in Patients With Mucosal Melanoma of Head and Neck in Intensity-modulated Radiotherapy Era
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2010 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In China, mucosal melanoma of head and neck (MMHN) account for 30-40% of all melanoma and the incidence is on the rise. The prognosis of MMHN is poor with the 5-year survival in a range between 20-30%. The evidence for the treatment of MMHN was weak since large-sample clinical researches are rare and no prospective clinical trial is reported. Surgery is the primary treatment modality for MMHN. However, it is difficult to extend the necessary surgery range for MMHN due to its limitation of being adjacent to the important anatomical structure in head and neck or by the considerations of the protection for organ function. As a result, the recurrence rate for surgery along was over 50%. Radiotherapy(RT) is the main approach for the multidisciplinary treatment for MMHN. Benlyazid et al. conclude the data from 13 centers and find that compared to surgery alone, the addition of post-surgery RT improve the survival; The 5-year locoregional failure rate for the surgery alone group and the RT+surgery group were 55.6% and 29.9%, respectively. Currently, the research into the prognosis factors is spare for the non-metastatic MMMHN received extended resection to primary tumor. It is necessary to undertake a prospective clinical research for MMHN in the endemic area to estimate efficacy and safety of primary surgery plus postoperative radiotherapy with or without adjuvant chemotherapy, as well as to recognize the risk distribution in this cohort of patients, provide the evidence to improve the stratification treatment strategies in the clinic.
Detailed Description
All the patients enrolled are confirmed without any evidence of distant metastasis. All the patients receive extended resection to primary tumor and post-surgery RT. The patients are prescribed a EQD2 of 65-70Gy to CTV1 (high-risk regions including tumor bed), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT). The Prophylactic irradiation to upper neck is is decided by radiation physicians and given a EQD2 of 70-77Gy to CTVnd (clinically negative lymph nodes), 50-55Gy to CTVn2（neck nodal regions). If there is residual tumor, a EQD2 of 70-77Gy is prescribed to GTV. Adjuvant chemotherapy (for example, Temozolomide) is prescribed or not according the consideration of radiation physicians during RT or after RT. The clinical characteristics, radiation dose, chemotherapy regimen and the toxicities of are documented by the radiation physicians.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucosal Melanoma
Keywords
mucosal melanoma, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
All the patients receive extended resection to primary tumor and post-surgery RT. The patients are prescribed a EQD2 of 70-77Gy to GTV (residual tumor), 65-70Gy to CTV1(high-risk regions including tumor bed and gross macroscopic residual tumor), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT)
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RT
Arm Type
Experimental
Arm Description
The patients are prescribed a EQD2of 65-70Gy to CTV1(high-risk regions including tumor bed), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT). The Prophylactic irradiation to upper neck is is decided by radiation physicians and given a EQD2 of 70-77Gy to CTVnd (clinically negative lymph nodes), 50-55Gy to CTVn2（neck nodal regions). If there is residual tumor, a EQD2 of 70-77Gy is prescribed to GTV.
Intervention Type
Radiation
Intervention Name(s)
RT
Intervention Description
All the patients receive extended resection to primary tumor and post-surgery RT. The patients are prescribed a EQD2 of 70-77Gy to GTV (residual tumor), 65-70Gy to CTV1(high-risk regions including tumor bed and gross macroscopic residual tumor), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT)
Primary Outcome Measure Information:
Title
Overall survival(OS)
Description
OS is calculated from the first day of therapy to the day of death, or to the last follow-up.
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Regional relapse-free survival(RRFS)
Description
RFS is calculated from the first day of therapy to regional failure from any cause. Regional relapses were diagnosed with clinical examination of the neck and, in doubtful cases, by fine needle aspiration or an MRI scan of the neck.
Time Frame
3 Year
Title
Local recurrence-free survival(LRFS)
Description
the first day of therapy to local failure from any cause. Local relapses were diagnosed by fibreoptic endoscopy and biopsy.
Time Frame
3 Year
Title
Distant metastasis-free survival (DMFS)
Description
DMFS is calculated from the first day of treatment to the date of first remote. Distant metastases were diagnosed by clinical symptoms, physical examinations, and imaging methods that included CT, MRI, bone scan, abdominal sonography, and/or PET-CT.
Time Frame
3 Year
Title
Number of participants with adverse events
Description
Number of participants with acute and late toxicity and treatment-related mortality.Adverse events were recorded according to the Common Terminology Criteria for Adverse Events (version 4.0) at each treatment visit, follow-up visit, and at the end of the study.
Time Frame
3 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histologically confirmed mucosal melanoma of head and neck (MMHN);
Tumor staged as stages III/IVA (according to the American Joint Committee on Cancer 7th edition staging system) arising from head and neck according to the radiology and clinical exam;
Prior local resection to primary tumor;
Radiologically confirmed (MRI, CT or PET-CT if necessary) no regional lymph node present, nor any evidence of distant metastasis;
Adequate marrow: white blood cell count of 4.0 × 109/L or more; absolute neutrophil of 2.0 × 109/L or more; haemoglobin concentrations of at least 90 g/L; platelet cell count of 100 × 109/L or more；
Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2.5×upper limit of normal (ULN)；
Adequate renal function: creatinine clearance rate of more than 60 mL/min;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
Expected lifespan > 3 months;
Patients must be informed of the investigational nature of this study and give written informed consent；
Patients must be consent to the follow-up till death, the study termination or the end of the study.
Exclusion Criteria:
Patients with histologically or radiologically distant metastasis or recurrence of primary tumor;
Any contraception to RT;
History of previous RT or chemotherapy;
Any severe previous or intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, serious comorbidities, or had active lupus erythematosus or scleroderma, unstable cardiac disease needing treatment, chronic obstructive pulmonary disease exacerbation or other respiratory illness needing treatment, or an acute or fungal infection requiring treatmen);
Prior malignancy within 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer;
Pregnancy or lactation;
Unable or unwilling to the compliance of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LiXia Lu, M.D.
Phone
+86-20-87343469
Email
lulx@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LiXia Lu, M.D.
Organizational Affiliation
Sun Yat-sen University Cancer Center,China, Guangdong
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
LiXia Lu, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
LiXia Lu
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lixia Ly, M.D.
Phone
China, Guangdong
Email
lulx@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Mucosal Melanoma of Head and Neck in Intensity-modulated Radiotherapy Era
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