E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cutaneous malignant melanoma |
cutaan maligne melanoom |
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E.1.1.1 | Medical condition in easily understood language |
malignant melanoma of the skin |
maligne melanoma van de huid |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of the primary tumor, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with VDR immunoreactivity in the primary tumour. |
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E.2.2 | Secondary objectives of the trial |
Furthermore it will be investigated
Whether the evolution of 25(OH)D3 serum levels during the study (secondary endpoint) depend on the genetic variability in the vitamin D pathway.
Whether VDR immunoreactivity correlates with stage at diagnosis (secondary endpoint)
Whether vitamin D levels at diagnosis correlate with stage at diagnosis (secondary endpoint), melanoma site (secondary endpoint) and melanoma subtype (secondary endpoint)
Whether genetic variability of Vitamin D pathway correlates with stage at diagnosis (secondary endpoint)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Older than 18 years and younger than 80 years of age.
2. Histologically proven malignant melanoma, stage IB to III Not participating in other clinical trial.
3. The only treatment for melanoma is surgical treatment.
4. Complete resection of melanoma.
5. Single primary invasive cutaneous melanoma (inclusion within 1 year after diagnosis).
6. Signed ethical committee approved informed consent
7. Serum phosphate and calcium at the entry of the study within normal range of the laboratory reference
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E.4 | Principal exclusion criteria |
1. Pregnant/lactating women or planning on becoming pregnant during the study
2. Known hypersensitivity to vitamin D or its components.
3. Pre-existing renal stone disease or chronic renal disease with eGRF < 30 mL/min/1.73 m2 or renal dialysis.
4. Liver failure or chronic liver disease with liver enzyme > 2 fold ULN (=upper limit of normal)
5. History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
6. History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
7. History of other malignancy within the last 5 years except for carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of the skin or in situ malignant melanoma.
8. Chronic alcohol abuse.
9. Medical or logistic problems likely to preclude completion of the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Melanoma subtype, as assessed clinically and histologically
2. Melanoma site, as clinically recorded
3. 25(OH)D3 serum levels 4. Stage of melanoma patient at diagnosis according to the 2009 AJCC Melanoma staging and classification
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Melanoma subtype, as assessed clinically and histologically: time of diagnosis
2. Melanoma site, as clinically recorded: time of diagnosis
3. 25(OH)D3 serum levels: time of diagnosis and at 6 months intervals
4. Stage of melanoma patient: timor of diagnosis according to the 2009 AJCC Melanoma staging and classification
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |