E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients admitted for treatment on a general thoracic surgery division with the following conditions:
Lung cancer
Esophageal cancer
Cancer of the gastroesophageal junction (GEJ) |
|
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 determine the 25(OH)Vitamin D -levels in the patient collective admitted for general thoracic surgery, and to initiate subsitution therapy in case of Vitamin D definicency. |
|
E.2.2 | Secondary objectives of the trial |
To assess the further course of the abovementioned collective. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Histologically proven lung cancer
Histologically proven esophageal cancer
Histologically proven cancer of the gastroesophageal junction (GEJ)
Age ≥18 years
Possibility of oral or enteral administration of the study medication (oral intake, nasogastric tube, jejunal tube, gastrostomy tube) |
|
E.4 | Principal exclusion criteria |
Moribund patient expected to die within 24 hours
Hypercalcaemia (total calcium >2.65 mmol/l OR ionized calcium >1.35 mmol/l)
Severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml)
Known granulomatous diseases (tuberculosis, sarcoidosis)
Known history of recent kidney stones (≤1 year)
Women of childbearing age
Pregnancy
Withdrawal of patients IC
Participation in other interventional studies
Patients unable to give informed consent |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Determination of the 25(OH)Vitamin D - levels in a patient collective requiring general thoracic surgery.
The main hypothesis of the study is, that high-dose supplementation of vitamin D will reduce perioperative/periinterventional morbidity and mortality and will prolong survival or tumour-free survival in patients treated for lung cancer or oesophageal carcinoma. |
|
E.5.2 | Secondary end point(s) |
Perioperative / Periinterventional course (duration of stay on ICU, total duration of stay, complications, in-hospital mortality)
Posttherapeutic course of lung cancer or oesophageal carcinoma (recurrence-free survival, interval to progression, overall survival) in the treatment group and in the control group
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.2.3.1 | Comparator description |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
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
|
Last visit of the last subject undergoing the trial. |
|
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 |