E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colorectal cancer |
Cáncer colorrectal |
|
E.1.1.1 | Medical condition in easily understood language |
Colorectal cancer |
Cáncer colorrectal |
|
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 | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061451 |
E.1.2 | Term | Colorectal cancer |
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 |
To evaluate safety of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma |
Evaluar la eficacia de la quimioterapia intraperitoneal hipertérmica (HIPEC) con Mitomicina C asociada a cirugía en el tratamiento del carcinoma colorrectal localmente avanzado |
|
E.2.2 | Secondary objectives of the trial |
1) To evaluate the effect on the overall survival (OS) at 12 months and 3 years of adding Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery
2) To evaluate the effect on the disease-free survival rates (DFS) at 12 months and 3 years of adding Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery
3) To evaluate safety (morbidity and mortality) of adding Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery |
1) Evaluar el efecto en la supervivencia global (OS) de la adición de HIPEC con Mitomicina C a la cirugía extendida a los 12 meses y 3 años.
2) Evaluar el efecto en la supervivencia libre de enfermedad (DFS) de la adición de HIPEC con Mitomicina C a la cirugía extendida a los 12 meses y 3 años.
3) Evaluar la seguridad (morbilidad y mortalidad) de la adición de HIPEC a la cirugía extendida del carcinoma colorrectal pT4. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Male and female patients between the ages of 18 and 75 years; 2) Adenocarcinoma of the colon, sigma and colon-sigma joint which represent cT4a/b in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual; 3) Lymph node involvement: N0, the presence of N1/2 according to the 7th edition of the AJCC is allowed, provided that they can be resectable; 4) Metastatic extent: M0; 5) Karnofsky index >70 o rPerformance status ?2; 6) Informed consent properly completed. |
1) Pacientes de ambos sexos, con edad >18 años y < 75 años; 2) Adenocarcinoma de colon, sigma y unión recto-sigma que presenten cT4a/b acorde a la séptima edición TNM de American Joint Committe on Cancer (AJCC). 3) Extensión ganglionar: N0, la presencia de N1/2 acorde a AJCC TNM 7ª edición es permitido siempre que puedan ser resecables. 4) Extensión metastásica: M0. 5) Índice de Karnofsky >70 o Performance status ?2. 6) Consentimiento informado debidamente cumplimentado. |
|
E.4 | Principal exclusion criteria |
1) Presence of metastatasis (M1); 2) Presence of unresectability criteria; 3) Urgent intervention for obstruction or perforation; 4) Extraperitoneal rectal cáncer (avoiding alterations for neoadyuvance); 5) Coexistence with another malignant neoplastic disease; 6) Severely altered liver, kidney and cardiovascular function; 7) Intolerance to treatment; 8) Administration of chemotherapy before the trial (use of neoadyuvance is discarded); 9) Pregnant or breastfeeding women. |
1) Presencia de metástasis (M1). 2) Presencia de criterios de irresecabilidad. 3) Intervención urgente por obstrucción o perforación. 4) Cáncer rectal extraperitoneal (evitando alteraciones por neoadyuvancia). 5) Coexistencia de otra enfermedad neoplásica maligna. 6) Función hepática, renal o cardiovascular severamente alteradas. 7) Intolerancia al tratamiento. 8) Administración de quimioterapia previa al ensayo (se descarta utilización de neoadyuvancia). 9) Mujeres en periodo gestacional o lactantes. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Locoregional Control (LC) in months and the 12 months and 3 years Locoregional Control Rate (LC %) |
Control locorregional (LC) en meses y tasa de control locorregional de la enfermedad (LC %) a los 12 meses, 3 años. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 months and 3 years |
12 meses y 3 años |
|
E.5.2 | Secondary end point(s) |
1) Peri and post-operative morbidity through Common Terminology Criteria for Adverse Events (CTCAE) and peri-operative mortality, up to 30 and 90 days after surgery 2) Overall survival (OS) in months and and Overall survival rate (% OS at 12 months and 3 years) 3) Disease-free survival rates (DFS) in months and Disease-free survival rates (% DFS at 12 months and 3 years) |
1) Morbilidad peri y posoperatoria mediante sistema de clasificación de eventos adversos CTCAE y mortalidad peri-operatoria, hasta los 30 y 90 días pos-intervención. 2) Supervivencia global (OS) en meses y tasa de supervivencia (% OS a los 12 m, 3 años). 3) Supervivencia libre de enfermedad (DFS) en meses y tasa de periodo libre de enfermedad (% DFS a los 12 m, 3 años). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 and 90 days 12 months and 3 years |
30 y 90 días 12 meses y 3 años |
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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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 15 |
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
|
LVLS |
Última visita 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 | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |