E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced localised non-metastatic pancreatic cancer (LANPC) |
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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 evaluate the activity, safety and feasibility of two chemoradiation treatments in the management of LANPC. If either is found to be active, safe and feasible to use it may be considered as experimental arm(s) of a future phase III trial.
Primary objective: In each arm of the trial assess the 39 weeks (from registration) progression-free survival, defined according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria.
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E.2.2 | Secondary objectives of the trial |
In each arm of the trial assess: 1) Toxicity, during and after treatment using NCI CTCAE v.3.0. Also, SAEs will be collected in real time 2) Quality of life 3) Overall survival 4) Progression-free survival (time to event). 5) Radiotherapy quality assurance 6) Adherence to protocol 7) Change over time of CA19-9 response
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients meeting the following criteria may be included in the trial:
1. Age ≥ 18 2. Histologically or cytologically proven malignancy of the pancreas 3. Locally advanced, non-metastatic, and inoperable (or operable but medically unfit for surgery) (as discussed at MDT) malignancy. The following types of interventions are allowed: a. palliative bypass procedure b. common bile duct stenting 4. Primary pancreatic lesion ≤7cm in diameter as measured by a CT scan of the thorax and abdomen that has been done within 4 weeks prior to the start of induction chemotherapy 5. WHO performance status 0-2 6. Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and haemoglobin ≥ 10g/dL 7. Adequate liver function tests: a. Serum bilirubin <35 micro mol/L. In participants who have had a recent biliary drain and whose bilirubin is descending, a value of ≤50µmol/L is acceptable. b. AST and ALT ≤2.5 x ULN, alkaline phosphatase ≤5 x ULN 8. Adequate renal function (GFR >50ml/min (Cockcroft & Gault) 9. Capable of giving, and given, informed consent 10. Potentially fertile participants should agree to use an adequate contraception method, which must be continued for 3 months after completion of chemotherapy
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E.4 | Principal exclusion criteria |
If any of the following criteria apply, participants cannot be included in the trial: 1. Women who are pregnant or breast feeding 2. Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease 3. Any participants with myocardial infarction or stroke within the last 6 months 4. Previous malignancies in the preceding 5 years except for in situ cancer of the uterine cervix and adequately treated basal cell skin carcinoma and early stage malignancy 5. Renal abnormalities such as polycystic kidneys or hydronephrosis or ipsilateral single kidney. 6. Previous radiotherapy to upper abdomen 7. Recurrent cancer following definitive pancreatic surgery 8. Lymphoma or neuroendocrine tumours of the pancreas
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E.5 End points |
E.5.1 | Primary end point(s) |
39 weeks (from registration) progression-free survival, defined according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
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 | 26 |
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 | Yes |
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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The end of the trial is when the last participant to be randomised finishes their protocol treatment. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |