E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colon carcinoma |
Colon carcinoom |
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E.1.1.1 | Medical condition in easily understood language |
Large bowel cancer |
Dikke darm kanker |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
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 |
Assess safety and feasibility of SLN identification using intravenous bevacizumab-800CW. Defined as: 1. Identification rate of SLN(s) or lymph node metastases with bevacizumab-800CW, Defined as the number of patients in which a SLN or lymph node metastases were detected due to fluorescence during surgery and/or pathology assessment / total number of procedure 2. Rate of adverse events related to bevacizumab-800CW (injection). Defined as the number of adverse events related towards bevacizumab-800CW / total number of procedures (n, %).
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Het bepalen van veiligheid en haalbaarheid van SWK identificatie, met behulp van intraveneuze bevacizumab-800CW injectie. Gedefinieerd als: 1. Percentage SLN detectie middels bevacizumab-800CW. 2. Complicaties gerelateerd aan bevacizumab-800CW (injectie). |
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E.2.2 | Secondary objectives of the trial |
1. Amount of fluorescence in lymph node metastases compared to lymph node without metastases 2. False-negative SLNs: The SLNs are negative whereas the non-sentinel nodes (NSNs) were positive (number). 3. True-negative SLNs: Both the SLNs and NSNs are negative (number). 4. Sensitivity: The number of patients with a positive SLN / the total number of node positive patients (n, %). 5. Upstaging: The number of patients with SLNs positive after ultrastaging / the number of patients who were node negative by H&E examination (n, %). 6. Aberrant lymph node status: The number of patients with aberrant lymph nodes, and the status of these lymph nodes 7. Accuracy: (The total number of patients with a positive SLN + the number of patients with a true-negative SLN) / number of patients with an identified SLN (n, %). 8. Negative predictive value (NPV): The number of true negative SLNs / (true negative + false negative SLNs). 9. Number of SLN identified |
1. Hoeveelheid fluorescentie in lymfeklieren met metastasen vergeleken lymfeklieren zonder metastasen. 2. False-negative SLNs: De SLN is negatief terwijl de non-SLN positief is. 3. True-negative SLNs: de SLN en de non-SLN zijn beide negatief 4. Sensitiviteit: Aantal patiënten met een positieve SLN / total aantal patiënten met lymfekliermetastasen 5. Upstaging: aantal patiënten met een positieve SLN na ultrastaging / totaal aantal patiënten. 6. Aberrant lymfeklier status: aantal patiënten met een aberrante lymfeklier en de status ervan. 7. Accuratesse: (totaal aantal patiënten met een positieve SLN + aantal patiënten met een true-negative SLN) / aantal patiënten met een SLN 8. Negatief voorspellende waarde (NPV): aantal patiënten met een true-negative SLN / (true-negative + false-negative SLN) 9. Aantal geïdentificeerde SLNs
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Oral and written informed consent (IC) - Aged 18 years and older - Pathologically confirmed and/or suspected cT1-3N0-2M0 colon carcinoma |
- Mondelinge en schriftelijke informed consent (IC) - 18 jaar en ouder - Pathologisch bevestigd en/of verdenking op colon carcinoom |
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E.4 | Principal exclusion criteria |
- Distant metastasis - Suspicion of cT4 disease based on pre-operative assessment - Metastatic or T4 disease discovered during intraoperative staging - Pregnancy, lactation or a planned pregnancy during the course of the study - Previous colon surgery, excluding appendectomy. - Contra-indication for laparoscopic/robotic surgery - Inadequately controlled hypertension with or without current antihypertensive medication. - Within 6 months prior to inclusion: myocardial infarction, TIA, CVA, pulmonary embolism, unstable angina pectoris, or uncontrolled chronic hepatic failure. - Regarding bevacizumab: Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies. Or an allergy for its components (Trehalose dehydrate, sodium phosphate, polysorbate 20, water for injections)
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- Metastasen op afstand - Verdenking van cT4 ziekte gebaseerd op preoperatieve onderzoek - Metastasen of T4 ziekte ontdekt tijdens de operatie. - Zwanger, geplande zwangerschap of borstvoeding gedurende het onderzoek. - Eerdere operatie van het colon, exclusief appendectomie. - Contra-indicatie voor laparoscopie of robot chirurgie. - Inadequaat behandelde hypertensie, met of zonder medicatie - In de afgelopen 6 maanden: myocardinfarct, TIA, CVA, longembolie, instabiele angina pectoris, ongecontroleerde chronisch leverfalen. - Betreffende bevacizumab: overgevoeligheid voor Chinese Hamster Ovary (CHO) cell producten, andere recombinante humane of gehumaniseerde antilichamen. Of een allergie voor de bestandsdelen (Trehalose-dehydraat, natriumfosfaat, polysorbaat 20, water voor injecties).
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E.5 End points |
E.5.1 | Primary end point(s) |
- Identification rate of SLN with bevacizumab-800CW - Number of adverse or allergic reactions towards bevacizumab-800CW
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- Identificatie ratio van SWK met bevacizumab-800CW - Aantal bijwerkingen of allergische reacties tegen bevacizumab-800CW |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Identification ration will be assesed intra-operatively Number of adverse/allergic events will be assessed intra and post-operatively |
Identificatie ratio wordt intra-operatief bepaald Aantal bijwerkingen/allergische reacties worden intra- en post operatief bepaald. |
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E.5.2 | Secondary end point(s) |
1. Amount of fluorescence in lymph node metastases compared to lymph node without metastases 2. False-negative SLNs: The SLNs are negative whereas the non-sentinel nodes (NSNs) were positive (number). 3. True-negative SLNs: Both the SLNs and NSNs are negative (number). 4. Sensitivity: The number of patients with a positive SLN / the total number of node positive patients (n, %). 5. Upstaging: The number of patients with SLNs positive after ultrastaging / the number of patients who were node negative by H&E examination (n, %). 6. Aberrant lymph node status: The number of patients with aberrant lymph nodes, and the status of these lymph nodes 7. Accuracy: (The total number of patients with a positive SLN + the number of patients with a true-negative SLN) / number of patients with an identified SLN (n, %). 8. Negative predictive value (NPV): The number of true negative SLNs / (true negative + false negative SLNs). 9. Number of SLN identified |
1. Hoeveelheid fluorescentie in lymfeklieren met metastasen vergeleken lymfeklieren zonder metastasen. 2. False-negative SLNs: De SLN is negatief terwijl de non-SLN positief is. 3. True-negative SLNs: de SLN en de non-SLN zijn beide negatief 4. Sensitiviteit: Aantal patiënten met een positieve SLN / total aantal patiënten met lymfekliermetastasen 5. Upstaging: aantal patiënten met een positieve SLN na ultrastaging / totaal aantal patiënten. 6. Aberrant lymfeklier status: aantal patiënten met een aberrante lymfeklier en de status ervan. 7. Accuratesse: (totaal aantal patiënten met een positieve SLN + aantal patiënten met een true-negative SLN) / aantal patiënten met een SLN 8. Negatief voorspellende waarde (NPV): aantal patiënten met een true-negative SLN / (true-negative + false-negative SLN) 9. Aantal geïdentificeerde SLNs |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All secondary endpoints will be collected postoperatively, after pathological assessment is completed. |
Alle secundaire eindpunten worden postoperatief gedaan, nadat de pathologie is uitgevoerd. |
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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 | No |
E.6.3 | Therapy | No |
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Open cohort, veiligheid haalbaarheid |
Open cohort, safety and feasibility |
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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.8.2.4 | Number of treatment arms in the trial | 1 |
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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End of the trial is after pathological assessment of all 5 patients. |
Het einde van de trial is indien pathologische analyse is gedaan bij alle 5 patiënten. |
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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 | |
E.8.9.1 | In the Member State concerned days | |