E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
gastroesophageal cancer |
oesophagus- en maagcarcinoom |
|
E.1.1.1 | Medical condition in easily understood language |
gastroesophageal cancer |
slokdarm- en maagkanker |
|
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 |
To compare the progression free survival (PFS1) and neurotoxity of first line treatment with F-Nal-IRI, CapCar and CapOx. |
Vergelijken van progressie vrije overleving (PFS1) en neurotoxiciteit van 3 FU-doublets. |
|
E.2.2 | Secondary objectives of the trial |
Secondary endpoints − Overall survival − Response rate according to RECIST 1.1 − Adverse events according to NCI CTC version 5.0 − Quality of life − Percentage of patients proceeding to subsequent lines of treatment after progression and describe the types of treatment − Reasons for forgoing subsequent treatment after progression − Comparison of above mentioned objectives for patients treated with and without nivolumab - Comparison of the progression free survival 2: time from reintroduction carboplatin, oxaliplatin or Nal-IRI after first moment of disease progression, untill disease progression
|
−Overleving −Response rate volgens RECIST 1.1 −Bijwerkingen volgens NCI CTC version 5.0 −Kwaliteit van leven −Percentage van patienten dat aan een volgende lijn behandeling start en de inhoud van die behandelingen −Redenen voor het starten van de volgende lijnen van behandeling -Vergelijking van bovenstaande eindpunten tussen patiënten behandeld met en zonder nivolumab - Vergelijking van de progressie vrije overleving 2: de tijd van herintroductie van carboplatin, oxaliplatin of Nal-IRI na de eerste progressie, tot aan de ziekte progressie
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
− Male or female adult patients (≥ 18 years). − Patients with histologically confirmed diagnosis of metastatic or irresectable HER2 negative adenocarcinoma of the stomach or oesophagus; patients with HER2 positive disease are eligible when treatment with trastuzumab is contraindicated. If histology cannot be obtained, cytology is acceptable to prove metastatic disease. − Patients with metastatic or irresectable adenocarcinoma of the stomach or oesophagus not pre-treated with chemotherapy or radiotherapy for irresectable or metastatic disease. Palliative radiotherapy on the primary tumor or a metastatic lesion is allowed if other untreated lesions eligible for evaluation are present. − Measurable disease as assessed by RECIST 1.1 − ECOG (WHO) performance status 0-2 − Patient has adequate bone marrow and organ function |
- volwassen patienten (≥ 18 jaar) -histologisch bewezen gemetastaseerd of irresectabel her 2 negatief adenocarcinoom van slokdarm of maag −meetbare ziekte volgens RECIST 1.1 −ECOG (WHO) performance status 0-2 -patienten met gemetastaseerd of irresectabel her 2 negatief adenocarcinoom van slokdarm of de maag die nog niet behandeld zijn met chemotherapie of radiotherapie voor irresectabele of gemetastaseerde ziekte. Palliatieve radiotherapie van de primaire tumor is toegestaan als andere niet behandelde laesies evalueerbaar zijn. |
|
E.4 | Principal exclusion criteria |
−Past or current malignancy other than entry diagnosis interfering with prognosis of metastatic esophagogastric cancer.
|
de aanwezigheid van een andere maligniteit die interfereert net de prognose van de slokdarm-maakkanker |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression free survival and neurotoxicity |
Progressie vrije overleving en neurotoxiciteit |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
CT scan every 9 weeks, questionnaire neurotoxicity every 3 weeks |
CT scan elke 9 weken vragenlijst neurotoxiciteit elke 3 weken |
|
E.5.2 | Secondary end point(s) |
− Overall survival − Response rate according to RECIST 1.1 − Adverse events according to NCI CTC version 5.0 − Quality of life − Percentage of patients proceeding to subsequent lines of treatment after progression and describe the types of subsequent treatments − Reasons for forgoing subsequent treatment after progression − Comparison of above mentioned objectives for patients treated with and without nivolumab |
− Overall survival − Response rate volgens RECIST 1.1 − Bijwerkingen volgens NCI CTC version 5.0 − Kwaliteit van leven − Percentage van patients die met een volgende lijn behandeld worden en het beschrijven van die behandeling − Redenen voor het niet doorgaan met een volgende lijn na progressie - Vergelijking van bovenstaande eindpunten tussen patiënten behandeld met en zonder nivolumab.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
CT scan every 9 weeks, questionnaire neurotoxicity every 3 weeks questionnaire quality of life every 9 weeks |
CT scan elke 9 weken vragenlijst neurotoxiciteit elke 3 weken vragenlijst kwaliteit van leven elke 9 weken |
|
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 | Yes |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 37 |
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
|
Last visit of the last subject |
laatste bezoek van de laatste patient |
|
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 | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |