E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Esophageal adenocarcinoma |
Slokdarm adenocarcinoom |
|
E.1.1.1 | Medical condition in easily understood language |
Esophageal cancer |
Slokdarmkanker |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
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 |
Validation of the accuracy of sentinel node navigation surgery (SNNS) for the detection of tumor-positive lymph nodes in patients with T1 esophageal adenocarcinoma and lymph node metastases.
|
Het valideren van de accuratesse van de schildwachtklierprocedure voor de detectie van tumor-positieve lymfeklieren in patiënten met een T1 slokdarmadenocarcinoom en lymfekliermetastasen. |
|
E.2.2 | Secondary objectives of the trial |
To introduce an esophageal preserving treatment regimen for high-risk T1b esophageal adenocarcinoma patients. |
Introduceren van een slokdarm besparend behandelalgoritme voor hoog-risico T1b slokdarmadenocarcinoom patiënten. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Esophageal adenocarcinoma, clinically staged as T1N1M0 with an indication for esophagectomy
2) Fit for endoscopy and surgery per institution’s standards
3) Older than 18 years of age at time of informed consent
4) Written informed consent |
1) Slokdarmadenocarciinoom, klinische stadiëring als T1N1M0 met indicatie voor slokdarmresectie
2) Klinische conditie waarbij endoscopie en chirurgie mogelijk is
3) Ouder dan 18 jaar ten tijde van informed consent
4) Getekend informed consent |
|
E.4 | Principal exclusion criteria |
1) Esophageal squamous cell carcinoma
2) Clinically staged as T>1, N>1 and/or M1
3) Neoadjuvant (chemo)radiation therapy
4) Known allergy for the radioactive tracer (technetium) or dye (indocyanine green)
5) Severe medical comorbidities precluding endoscopy and/or surgery
6) Refusing or unable to provide written informed consent |
1) Slokdarmplaveiselcelcarcinoom
2) Klinische stadiëring als T>1, N>1 en/of M1
3) Neodjuvante (chemo)radiatie therapie
4) Bekende allergie voor de radioactieve tracer (technetium) of kleurstof (indocyanine groen)
5) Comorbiditeit waardoor endoscopie en/of chirurgie niet mogelijk is
6) Weigeren of niet in staat getekend informed consent te verstrekken |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients in whom tumor-positive LN(s) are detected as SN(s); defined as the number of patients with 1 or more tumor-positive LNs detected as SNs, reported separately per type of detection (SPECT/CT, probe-based or NIR camera). |
Percentage patiënten waarin tumorpositieve lymfeklieren worden gedetecteerd als schildwachtklieren; gedefinieerd als het aantal patiënten met 1 of meer tumorpositieve lymfeklieren gedetecteerd als schildwachtklieren, separaat genoteerd per type detectie methode (SPECT/CT, laparoscopische probe of NIR camera). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After histopathological assessment of surgical resection specimens (lymph nodes and esophagus). |
Na histopathologische beoordeling van chirurgische resectiepreparaten (lymfeklieren en slokdarm). |
|
E.5.2 | Secondary end point(s) |
1) Percentage of patients with a detectable SN, either on SPECT/CT, probe-based or with a NIR camera.
2) Number of resected SN, location documented.
3) Ratio of number of dissected SNs and number of detected SNs on imaging.
4) Number of tumor-positive dissected SNs, subdivided per LN station.
5) Ratio of number of tumor-positive dissected SNs and number of detected SNs on imaging.
6) Concordance of pre-operative SPECT/CT and perioperative probe-based and ICG-based detection of SNs.
7) Additional yield of ICG-based SN detection over technetium SN detection.
8) Number of detectable SNs, either on SPECT/CT, probe-based or with a NIR camera, which could not be dissected during surgery, location and reason documented.
9) Procedure time of SNNS.
10) Incidence and severity of all adverse events. |
1) Percentage patiënten met een detecteerbare schildwachtklier, door middel van SPECT/CT, laparoscopische probe of near-infrared camera.
2) Aantal verwijderde schildwachtklieren per lymfeklierstation.
3) Ratio tussen het aantal verwijderde schildwachtklieren en het aantal gedetecteerde schildwachtklieren op imaging.
4) Aantal tumorpositieve verwijderde schildwachtklieren per lymfeklierstation.
5) Ratio tussen het aantal tumorpositieve verwijderde schildwachtklieren en het aantal gedetecteerd schildwachtklieren op imaging.
6) Overeenstemming tussen preoperatieve SPECT/CT en peri-operatieve detectie op basis van probe en ICG van schildwachtklieren.
7) Meerwaarde in detectie van schildwachtklieren op basis van ICG in vergelijking met detectie van schildwachtklieren met technetium.
8) Aantal detecteerbare schildwachtklieren, door middel van SPECT/CT, laparoscopische probe of NIR camera, welke niet verwijderd konden worden tijdens operatie, per lymfeklierstation en met reden.
9) Proceduretijd van de schildwachtklierprocedure.
10) Incidentie en ernst van alle adverse events. . |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After surgical procedure and histopathological assessment of surgical resection specimens (lymph nodes and esophagus). |
Na chirurgische procedure en histopathologische beoordeling van chirurgische resectiepreparaten (lymfeklieren en slokdarm). |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 3 |
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 | 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |