E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A population of malignant transformation stem cells, called tumor stem cells, extremely resistant to chemotherapeutic drugs, has been identified as the origin of pancreatic cancer. In our study, we developed a new therapeutic model, characterized by the application of hyperthermal intraabdominal chemotherapy with Gemcitabine, in order to eliminate locoregional tumor stem cells and improve the prognosis of neoplastic pancreatic disease |
Se ha identificado como origen del cáncer de páncreas una población de células madre con transformación maligna, llamadas células madre tumorales, extremadamente resistentes a fármacos quimioterápicos. En nuestro estudio desarrollamos un nuevo modelo terapéutico, caracterizado por la aplicación de quimioterapia intraabdominal hipertérmica con Gemcitabina, con el fin de eliminar de forma locorregional las células madre tumorales y mejorar el pronóstico de la enfermedad neoplásica pancreática. |
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E.1.1.1 | Medical condition in easily understood language |
We apply hyperthermal intraabdominal chemotherapy to eliminate tumor stem cells, chemotherapeutic drug resistance and improve the prognosis of pancreatic cancer. |
Aplicamos quimioterapia intraabdominal hipertérmica para eliminar a las células madre tumorales, resistentes a los fármacos quimioterápicos y mejorar el prónostico del cáncer de páncreas. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
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 identify the survival and morbidity and mortality associated with treatment with cytoreductive surgery and HIPEC with Gemcitabine compared to the group with conventional treatment (Cytoreductive surgery with systemic chemotherapy) |
Identificar la supervivencia y la morbimortalidad asociada al tratamiento mediante cirugía citorreductora y HIPEC con Gemcitabina respecto al Grupo con tratamiento convencional (Cirugía citorreductora junto a quimioterapia sistémica) |
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E.2.2 | Secondary objectives of the trial |
To identify the adverse effects, complications associated with treatment with cytoreductive surgery and HIPEC with Gemcitabine compared to the Group with conventional treatment (Cytoreductive surgery with systemic chemotherapy) |
Identificar los efectos adversos, complicaciones asociada al tratamiento mediante cirugía citorreductora y HIPEC con Gemcitabina respecto al Grupo con tratamiento convencional (Cirugía citorreductora junto a quimioterapia sistémica) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Surgically resectable pancreatic adenocarcinoma |
Adenocarcinoma de páncreas resecable quirúrgicamente |
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E.4 | Principal exclusion criteria |
· Voluntary refusal to participate in the trial · Existence of distant or locoregional disease that contraindicates surgical treatment, diagnosed preoperatively or in the intraoperative act · Existence of synchronous neoplastic disease · Exclusion after perioperative anesthetic study |
· Rechazo voluntario a participar en el ensayo · Existencia de enfermedad a distancia o locorregional que contraindica tratamiento quirúrgico, diagnosticado de forma preoperaoria o bien en el acto intraoperatorio · Existencia de enfermedad neoplásica sincrónica · Exclusión tras estudio perioperatorio anestésico |
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E.5 End points |
E.5.1 | Primary end point(s) |
Survival Morbidity and mortality |
Supervivencia Morbimortalidad |
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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) |
Adverse effects Complications Mortality |
Efectos adversos Complicaciones Mortalidad |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the hospital stay |
Durante la estancia hospitalaria |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Survival Disease-free period |
Supervivencia Período libre de enfermedad |
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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) | 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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There is a minimum follow-up period of 24 months |
Se prevé un periodo de mínimo de seguimiento de 24 meses |
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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 | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |