- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01264874
MelaViD: A Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients (MelaViD)
Phase III, Randomized, Double Blind Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Milan, Italy, 20141
- European Institute of Oncology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-75 years old with newly diagnosed histologically proven resected melanoma
- Stage: IIa (T2b, T3a), IIb (T3b T4a) and IIc (T4b), N0, M0
- Signed informed Consent
- Willingness to provide blood samples
- Performance Status of 0-1
- Hematopoietic functionality at the entry of the study: leukocytes, platelets, haemoglobin and neutrophiles within the normal limits of laboratory references
- Hepatic and renal functionality at the entry of the study within the normal range of each laboratory
- Serum and urinary calcium within the upper limit of laboratory references.
Exclusion Criteria:
- Primary not cutaneous melanoma
- Clinical/radiological evidence or laboratory/pathology report of not completely resected melanoma
- History of cancer (other than Carcinoma in situ (CIN) and non melanoma skin cancere (NMSC)
- Current daily use of at least 600 IU/day of supplemental vitamin D or calcitriol or high dose of calcium therapy (e.g. calcium citrate with vitamin D) within the prior 6 months greater than 600 mg calcium per day during study
- History of recurrent renal calculi or hypercalcemia (>10mg/dl), current and chronic use of oral corticosteroids
- History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, Crohn disease or tropical sprue)
- History of small intestinal resection (e.g., ileal bypass surgery for treatment of morbid obesity resection > 50 % of slim bowel)
- Hypersensitivity to cholecalciferol or one of its components
- Chronic liver disease, chronic renal disease, or renal dialysis
- History of parathyroid disease and sarcoidosis
- Pregnancy or breast feeding or planning on becoming pregnant during the 3 years of treatment
- Chronic alcoholism
- Any medical condition that in the physician's opinion would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis, patients treated pharmacologically for obesity
- Any logistic condition that do not allow follow-up of the disease of the patient.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
matched placebo
|
For 3 years IU every 50 days
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Experimental: Vitamin D3
Vitamin D3 administration
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100000 IU every 50 days for 3 years
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease free survival and Overall Survival
Time Frame: 3 years of treatment and 2 of follow up
|
Disease free survival (DFS) will be the primary end-point of efficacy in this Phase III trial. It will be measured from the date of randomization to the date of progression or death, whatever the cause. Overall Survival will be also evaluated and it is defined as the time from the date of randomization to the date of death from any cause or to the date of last follow-up. |
3 years of treatment and 2 of follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Vitamin D receptors and 25(OH)D by Breslow thickness.
Time Frame: baseline and after 1 year of treatment
|
Evaluation at baseline of Vitamin D receptors and 25(OH)D by Breslow thickness. Change in time of 25(OH)D serum level by VDR and other genes involved in vitamin D metabolisms. Percentages of patients at desired levels of 25(OH)D (30 ng/ml) during 1 year. Toxicity. Compliance. OS. |
baseline and after 1 year of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alessandro Testori, MD, European Institute of Oncology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
Other Study ID Numbers
- S480/209
- 2009-012049-46 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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