E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient presenting unresectable peritoneal metastases from digestive system, ovary or primary peritoneal origin |
Pacientes que presentan metástasis peritoneales irresecables de origen digestivo, ovarico o peritoneal primario
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E.1.1.1 | Medical condition in easily understood language |
Those patients in whom a tumor from the digestive system, ovary or peritoneum has spread into the abdomen and it is not possible to resect all the implants |
Aquellos pacientes en los que un tumor del aparato digestivo, ovario o peritoneo se haya extendido en el abdomen y no sea posible resecar todos los implantes. |
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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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051676 |
E.1.2 | Term | Metastases to peritoneum |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
The main objective of this project is to establish the efficacy of the administration of PIPAC in patients with unresectable peritoneal metastases of gynecological, digestive or primary peritoneal origin, in terms of tumor regression objectified by biopsies, measurement of PCI and clinical parameters (CT and symptoms ). A reduction of the mean PGRS score from 2.04 to 1.56 or in 67% of patients is expected. |
El objetivo principal de este proyecto es establecer la eficacia de la administración de PIPAC en pacientes con metástasis peritoneales no resecables de origen ginecológico, digestivo o primario peritoneal, en términos de regresión tumoral objetivada mediante biopsias, medición del PCI y parámetros clínicos (TAC y síntomas). Se busca una reducción en la media de las determinaciones mediante la escala PGRS de 2,04 a 1,56 o que existe una reducción significativa en al menos el 67 % de los pacientes |
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E.2.2 | Secondary objectives of the trial |
To determine the quality of life, overall survival and the safety profile of the therapy in terms of morbidity and mortality associated with the procedure.
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Determinar calidad de vida, supervivencia y el perfil de seguridad de la terapia en términos de morbimortalidad asociada al procedimiento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age between 18 and 75 years - Diagnosis of unresectable peritoneal carcinomatosis - (Decided in tumor board) - Diagnosis of peritoneal carcinomatosis of the following origins: - High-grade serous ovarian carcinoma unresponsive to 2 lines of intravenous chemotherapy - Colon adenocarcinoma - Gastric adenocarcinoma - Epithelioid variety of peritoneal mesothelioma - ECOG <= 2 - Patients in whom resective procedures or intestinal anastomoses are NOT going to be performed - Signature of the informed consent
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- Edad entre 18 y 75 años - Diagnóstico de carcinomatosis peritoneal no resecable - (Decidido en comité de tumores) - Diagnóstico de carcinomatosis peritoneal de los siguientes orígenes: - Carcinoma seroso de alto grado ovárico sin respuesta a 2 lineas de quimioterapia intravenosa - Adenocarcinoma de colon - Adenocarcinoma gástrico - Mesotelioma peritoneal variedad epitelioide - ECOG <=2 - Pacientes en los que NO se van a realizar procedimientos resectivos o anastomosis intestinales - Firma del consentimiento informado |
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E.4 | Principal exclusion criteria |
- Distant extraperitoneal metastases - Life expectancy <3 months - Presence of intestinal obstruction - Severe organ or system dysfunction - ECOG> 2 - Contraindication of administration of the chemotherapeutic drug contained in the specific protocol for that tumor - Previous abdominal surgery in the 4 weeks prior to administration - Patients with concomitant administration of immunosuppressants - Pregnant or breastfeeding patients - Decompensated ascites (> 3000 c.c.)
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- Metástasis extraperitoneales a distancia - Esperanza de vida < 3 meses - Presencia de obstrucción intestinal - Disfunción orgánica o de sistema severa - ECOG >2 - Contraindicación de administración del fármaco quimioterápico contenido en el protocolo específico para ese tumor - Cirugía previa abdominal en las 4 semanas previas a la administración - Pacientes con administración concomitante de inmunosupresores - Pacientes embarazadas o en fase de lactancia - Ascitis descompensada (> 3000 c.c.) |
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E.5 End points |
E.5.1 | Primary end point(s) |
To establish the efficacy in terms of histological tumor regression using the PGRS score of the administration of pressurized intraperitoneal chemotherapy in patients |
Establecer la eficacia en términos de regresión histológica tumoral mediante la puntuación PGRS de la administración de quimioterapia intraperitoneal presurizada en pacientes |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After each PIPAC procedure (every 4-6 weeks) |
Tras cada procedimiento de PIPAC (cada 4-6 semanas) |
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E.5.2 | Secondary end point(s) |
- Evaluate quality of life using a questionnaire approved for this purpose - Evaluate Overall survival - Evaluate postoperative morbidity - Evaluate adverse events |
- Evaluar la calidad de vida mediante un cuestionario aprobado para tal fin - Evaluar la supervivencia global - Evaluar la morbilidad postoperatoria - Evaluar eventos adversos |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After each PIPAC procedure (every 4-6 weeks) |
Tras cada procedimiento de PIPAC (cada 4-6 semanas) |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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) | 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
| 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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The end of the trial will occur after all recruited patients have received the PIPAC procedure and a 24-month follow-up has been completed for the last patient |
El final del ensayo se producirá después de que todos los pacientes reclutados hayan recibido el procedimiento PIPAC y se haya completado un seguimiento de 24 meses para el último paciente. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |