E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007071 |
|
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 |
The study itself is split into two sequential steps: Feasibility step including a randomization to study arms. Such a randomization during the feasibility step is required - to compare events observed in patients under protocol treatment vs events observed in patients receiving chemotherapy alone, - to more quickly reach the target of the possible Phase III step. Phase III step including a randomization to study arms The primary objective of the feasibility step will be to assess the feasibility and tolerability of the experimental arm in order to decide whether the randomized Phase III step can be or not carried out. The primary objective of the Phase III step will be to investigate if the experimental treatment consisting of gemcitabine followed by gemcitabine with concomitant radiation can extend the survival of patients as compared to gemcitabine alone. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
History of pancreas head adenocarcinoma with R0 pancreaticoduodenectomy Documented histological examination of surgical margins including retroperitoneal margin. The examination must have been performed during the surgical process and by using frozen sections. Proper documentation related to the number of lymph nodes (< 10 lymph nodes vs ≥ 10 lymph nodes) examined according to the UICC 1997 criteria Adequate liver (bilirubin < 1.5 times normal, ASAT / ALAT< 3.0 times normal) and renal (creatinin < 1.2 mg/dl) functions Presence of adequate contraception in fertile patients. Pregnant and lactating women are excluded. Hb> 9.0 g/dl or 5.6 mmol/L, platelets > 150000 /mm3 , WBC > 3500/mm3 Abdominal spiral CT scan (with contrast enhancement) performed after surgery and/or a spiral CT scan performed before surgery but not older than 8 weeks at the time of randomization Age > or = 18 ECOG/WHO PS < or = 2 Complete recovery from surgery within 8 weeks Before patient registration/randomization, written informed consent must be given according to ICH GCP, and national/local regulations Before patient registration /randomization , QoL assessment should have been completed |
|
E.4 | Principal exclusion criteria |
No previous or coexistant malignant disease except BCC of the skin or carcinoma in situ of the cervix No previous chemotherapy or radiotherapy
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial No periampullary cancer |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints: ‘Feasibility’ Study: Feasibility: Full completion of the administration of the experimental treatment Tolerability: Acute and late toxicity. These toxicities will determine if the full completion of the experimental treatment is feasible.
Phase III Study: Overall survival Secondary endpoints: Phase III Study: Disease free survival, sites of recurrence, toxicity, quality of life |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
|
End of study occurs when all of the following criteria have been satisfied: 1. Thirty days after all patients have stopped protocol treatment 2. The trial is mature for the analysis of the primary endpoint as defined 3. The database has been fully cleaned and frozen for this analysis |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |