E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The medical condition to be investigated is anaemia in patients with oesophageal or gastric cancer planned to undergo palliative chemotherapy. |
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E.1.1.1 | Medical condition in easily understood language |
The medical condition to be investigated is anaemia (low blood count) in patients with gullet or stomach cancer planned to undergo chemotherapy aimed at symptom control and prolonging life (not cure). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002062 |
E.1.2 | Term | Anaemia iron deficiency |
E.1.2 | System Organ Class | 100000004851 |
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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 feasibility of a larger trial, ie determine study size, ensure logistics adequate, to review patient uptake etc. |
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E.2.2 | Secondary objectives of the trial |
To investigate whether the use of intravenous Iron (Monofer®) improves the quality of life of patients undergoing palliative treatment of upper gastrointestinal adenocarcinoma.
To investigate whether the use of intravenous Iron (Monofer®) reduces the need for blood transfusions in patients undergoing palliative treatment of upper gastrointestinal acancer (adenocarcinoma).
To assess whether the use of intravenous Iron (Monofer®) improves the outcome, e.g in terms of complication rates and chemotherapy completion rates, in patients undergoing palliative treatment of upper gastrointestinal adenocarcinoma.
To investigate whether the use of intravenous Iron (Monofer®) improves the blood results of patients undergoing palliative treatment of upper gastrointestinal adenocarcinoma. These blood results reflect iron stores in the body |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Anaemic as defined by local laboratory normal range(Males<13g/dL, Females<12g/dL) 2. Male or Female aged over 18years 3. Participant is willing and able to give informed consent for participation. 4. Diagnosed with histologically proven oesophageal, gastric or GOJ adenocarcinoma. 5. Treatment selected is palliative chemotherapy 6. Medically fit for initiation of palliative chemotherapy. 7. Able (in the Investigators opinion) and willing to comply with study requirements. 8. Willing to allow his/her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
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E.4 | Principal exclusion criteria |
1. Patients who following investigation do not have a histological diagnosis of upper GI adenocarcinoma. 2. Female participants who are pregnant, lactating or planning a pregnancy during the course of the study. 3. Patients with evidence of iron overload or disturbances in utilisation of iron as stated in the product SPC. 4. Known haematological disease that, in the investigators opinion would confound any changes in blood results. 5. Features necessitating urgent surgery at inclusion 6. Previous allergy to intravenous iron or related iron products. 7. Patients who are unable to consent. 8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. 9. Donation of blood during the study. 10. Prisoners and minors (<18 years) 11. Non-iron deficiency anaemia (e.g. haemolytic anaemia) 12. Hypersensitivity to the active substance or to any of the excipients. 13. Patients with a history of asthma, allergic eczema or other atopic allergy 14. Decompensated liver cirrhosis and hepatitis 15. Rheumatoid arthritis with symptoms or signs of active inflammation
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E.5 End points |
E.5.1 | Primary end point(s) |
This is a Pilot study to assess feasibilty of a larger trial. We hope to review patient uptake, drop out, logistics of iron administration etc to aid in the design of a larger study. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At recruitment (T=0). On the first day of chemotherapy cycle 1 (T= approx +4 weeks) On the first day of chemotherapy cycle 3 (T= approx +7 weeks) On the first day of chemotherapy cycle 3 (T= approx +10 weeks) |
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E.5.2 | Secondary end point(s) |
Changes in quality of life as defined by the EQ-5D and FACT-an validated quality of life questionnaires. Variations in levels of haemoglobin and haematinic markers (full blood count, ferritin, iron, transferrin, transferrin saturation, erythropoietin). Rates of blood transfusion pre and intra-operatively. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At recruitment (T=0). On the first day of chemotherapy cycle 1 (T= approx +4 weeks) On the first day of chemotherapy cycle 3 (T= approx +7 weeks) On the first day of chemotherapy cycle 3 (T= approx +10 weeks) |
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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 | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard clinical practice as determined by the clinical team |
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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 | 2 |
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 | 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 | 3 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 24 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 24 |