E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Resectable colorectal carcinomatosis. |
Carcinosi colorettale resecabile. |
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E.1.1.1 | Medical condition in easily understood language |
Peritoneal carcinomatosis. |
Carcinosi peritoneale. |
|
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050035 |
E.1.2 | Term | Metastatic colon cancer |
E.1.2 | System Organ Class | 100000004864 |
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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 |
Evaluate the role of cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy compared to standard chemotherapy in term of overall survival. |
Valutare il ruolo della Chirurgia Cito-Riduttiva+Chemioterapia Ipertermica IntraPeritoneale rispetto alla chemioterapia sistemica, confrontando i due trattamenti in termini di sopravvivenza complessiva. |
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E.2.2 | Secondary objectives of the trial |
Evaluate disease-free survival, toxicity of two treatments and their impact on quality of life. |
Valutare la sopravvivenza libera da malattia, la tossicità dei due trattamenti e il loro impatto sulla qualità di vita. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histologically documented colorectal carcinomatosis • Minor/moderate peritoneal carcinomatosis with a Peritoneal Cancer Index (PCI) lower than 20 evaluated by CT and/or PET CT imaging • Patient between age 18 and 75 years. • ECOG 1-2 • ASA score 1-2 • Clinical, instrumental and biohumoral signs of bone marrow, hepatic, renal, pulmonary or cardiac insufficiency absent • Patients must be available for follow up • Signed Informed Consent |
• Diagnosi istologica di carcinoma colorettale • Carcinosi peritoneale di lieve/media entità con un Peritoneal Cancer Index (PCI) inferiore a 20 valutato radiologicamente con TAC e/o PET CT. • Età compresa tra 18 e 75 anni • Performance status ECOG 1-2 • ASA score 1-2 • Non segni clinici, strumentali e bioumorali di insufficienza midollare, epatica, renale, polmonare e cardiaca • Disponibilità di sottoporsi a follow-up • Consenso informato scritto |
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E.4 | Principal exclusion criteria |
• Extra-peritoneal metastatic localization (retroperitoneum, lymphnodes, liver or lung) • Prior first-line chemotherapy treatment for peritoneal carcinomatosis(adjuvant therapy excluded) • Prior intraperitoneal chemohyperthermic (HIPEC) treatment • Positive history of malignancies for at least 3 years, with the exception of basal cell carcinoma • Evidence of cardiovascular disease (history of congestive heart failure or LVEF <40%) • Evidence of renal disease (creatinine level >1.5 than the normal institutional limits or creatinine clearance <60 mL/min) • Evidence of hepatic disease (ASAT, ALAT, bilirubin >1.5 than the normal institutional limits, PT) • Evidence of hematopoietic disease (WBC <4000/mm3; neutrophil count <1500/mm3; platelets < 80000/mm3) • Evidence of pulomonary disease (BPCO or other restrictive lung disease with FEV1 <50% or a DLCO <40% than the normal limits for age) |
• Metastasi a localizzazione extra-peritoneale (retroperitoneo, linfonodi a distanza, fegato e polmone) • Precedente prima linea di chemioterapia sistemica per carcinosi peritoneale (terapie adiuvanti escluse) • Pregresso trattamento chemioipertermico intraperitoneale • Anamnesi positiva per neoplasie negli ultimi tre anni, ad esclusione del carcinoma basocellulare cutaneo • Alterata funzione cardiaca (scompenso cardiaco congestizio pregresso o FE <40%) • Alterata funzione renale (creatinina >1.5 volte il valore normale o creatinina clearance< 60 mL/min). • Alterata funzione epatica (AST, ALT, bilirubina > 1.5 volte il valore normale, PT) • Alterata funzione ematopoietica (leucociti<4000/mm3; neutrofili <1500/mm3;piastrine < 80000/mm3) • Alterata funzione polmonare (BPCO o altri deficit restrittivi polmonari con FEV1 < 50% or a DLCO < 40% del valore normale per età) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival from randomization. |
Sopravvivenza complessiva dalla randomizzazione. |
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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) |
• Disease-free survival from randomization • Evaluated of treatment toxicity according to the NCI-CTCAE v.4 • Quality of life with EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires, and HADS Concern Checklist |
• Sopravvivenza libera da malattia dalla randomizzazione • Tossicità dei trattamenti valutata in accordo al sistema NCI-CTCAE v.4 • Qualità della Vita valutata con i questionari EORTC QLQ-C30, EORTC QLQ-CR29, HADS e Concern Checklist |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Disease-free survival from randomization: 6 years. • Toxicity: until third year. • Quality of life: 1 years. |
• Sopravvivenza libera da malattia dalla randomizzazione: 6 anni. • Tossicità: fino a 3 anni. • Qualità di vita: 1 anno. |
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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 | 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 | 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
| 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 | 14 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |