E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adjuvant hyperthermic intraperitoneal chemotherapy in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicenter trial |
Adjuvante hypertherme intraperitoneale chemotherapie bij patiënten met een colon carcinoom en een hoog risico op peritonitis carcinomatosa; de multicenter gerandomiseerde COLOPEC studie |
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E.1.1.1 | Medical condition in easily understood language |
colon cancer
peritoneal carcinomatosis
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colon carcinoom
peritonitis carcinomatosa
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 |
The aim is to determine the effectiveness of adjuvant HIPEC using oxaliplatin following a curative resection of a pT4 or intra-abdominally perforated CRC in preventing the development of PC in comparison to the standard adjuvant systemic treatment |
Het doel van het onderzoek is om de effectiviteit te bepalen van adjuvante HIPEC met oxaliplatin in het voorkomen van peritonitis carcinomatosa in verglijking met de standaard adjuvante chemotherapie in patienten die een curatieve resectie hebben ondergaan van een pT4 of een intra-abdominaal geperforeerde colorectaal carcinoom |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are treatment related toxicity, incidence of PC, sensitivity of imaging to detect PC during follow-up, differences in patterns of dissemination (peritoneal plus or minus distant metastases), disease-free survival, overall survival, quality of life and costs. |
Behandeling gerelateerde toxcitieit, incidenite van peritonitis carcinomatosa, senisitiviteit en specificiteit van de beeldvorming tijdens follow-up voor detectie van PC, ziekte vrije overleving, totale overleving, kwaliteit van leven en kosten |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(1) age between 18 and 75 years. (2) adequate clinical condition to undergo re-laparoscopy or re-laparotomy within either 10 days or between week 5-8 from primary resection. (3) written informed consent (4) white blood cell count at least 3000/mm3, platelet count at least 100.000/mm3. (5) no bleeding diathesis or coagulopathy. (6) creatinine normal or creatinine clearance at least 50 ml/min. |
(1) Leeftijd tussen 18 en 75 jaar. (2) De klinische conditie van de patient is goed genoeg om een relaparotomie danwel relaparoscopie binnen 10 dagen of tussen 5-8 weken naar primaire resectie te ondergaan. (3) Ingevuld toestemmingsformulier. (4) Serologische witte bloedcel aantal van minimaal 3000/mm3 en een serologische bloedplaatjes aantal van minimaal 100.000/mm3. (5) geen hemorragische diathese dan wel coagulopathy. (6) serologische creatine waarde of een creatinine klaring van minimaal 50 ml/min. |
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E.4 | Principal exclusion criteria |
(1) postoperative complications that interfere with adjuvant HIPEC within 8 weeks (i.e. persisting intra-abdominal abscess, significant fascial dehiscence, enteric fistula). (2) liver and/or lung metastases. (3) pregnant or lactating women. (4) unstable or uncompensated respiratory or cardiac disease. (5) serious active infections. (6) other concurrent chemotherapy. (7) hypersensitivity for fluorouracil folinic acid (calciumfolinate) or another substance of leucovorin or Oxaliplatin. (8) Stomatitis, ulceration in the mouth or gastrointestinal tract. (9) severe diarrhea (10) severe hepatic and / or renal dysfunction. (11) plasma bilirubin concentrations greater than 85 μmol/l. (12) Pernicious anemia or other anaemias due to vitamin B12 deficiency.(13) peripheral sensory neuropathy with functional impairment. |
(1) postoperative complicaties die adjuvante HIPEC binnen 8 weken onmogelijk maken ( b.v. persisterend intra-abdominaal abces, persisterende fasciedehiscentie, of darmfistel). (2) lever en/of long metastasen. (3) zwangeren of lacterende vrouwen. (4) instabiele of gedeompenseerde respiratoire of cardiale ziektes. (5) ernstige actieve infecties. (6) andere gelijktijdige chemotherapie. (7) overgevoeligheid voor fluorouracil voor folinezuur (calciumfolinaat) of voor één van de bestanddelen van leucovorin of oxaliplatine. (8) stomatitis, ulceraties in de mond en het maagdarmkanaal (9) ernstige diarree (10) sterk verminderde lever- en/of nierfunctie (11) bilirubineplasmaconcentratie hoger dan 85 μmol/l. (12) Pernicieuze anemie of andere anemieën als gevolg van een tekort aan vitamine B12. (13) een perifere sensore neuropathie met functieverlies.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is peritoneal recurrence-free survival at 18 months. |
Peritoneaal recidief vrije overleving 18 maanden na de primaire resectie |
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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) |
• Treatment related toxicity, including 30-day complication rate and re-admission rate
• Hospital stay
• Incidence of Peritonis carcinomatosa (PC)
• Sensitivity of imaging to detect PC during follow-up
• Differences in patterns of dissemination (peritoneal plus or minus distant metastases)
• Disease-free survival
• Overall survival
• Quality of life
• Costs
• PC during diagnostic laparoscopy at 18 months
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• Behandeling gerelateerde toxiciteit, inclusie 30 dagen complicaties en heropname
• ziekenhuisverblijf
• Incidentie van peritonitis carcinomatosa (PC)
• Sensitiviteit van beeldvorming tjidens follow-up
• verschillen in dissiminatie patronen ( Peritoneum plus of min afstandsmetastasen)
• Ziekte vrije overlevin
• totale overleving
• kwaliteit van leven
• kosten
• PC tijdens diagnostische laparoscopie |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
3, 6, 12, 18, 24, 36, 48 and 60 months |
3, 6, 12, 18, 24, 36, 48 en 60 maanden |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
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) | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
de standaard behandeling namelijk adjuvante chemohterapie |
Standard adjuvant chemotherapy |
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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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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 | Yes |
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 trial will be completed at 60 months or will be terminated if a serious treatment-related adverse event occurs, making it impossible to recruit new patients or to continue the treatment of patients already recruited for medical or ethical reasons. |
The gehele studie is voltooid na 60 maanden. Tevens wordt de studie beeindigt als er een serieuse behandeling gerelateerde uitkomst optreed, wat het onmolgeijk maakt om nieuwe patienten te includeren of om de behandeling te continueren in patienten die al behandeld worden of om medische dan wel ethische redenen. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |