Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal ā¦ (NCT03777813) | Clinical Trial Compass
CompletedPhase 2
Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer
France112 participantsStarted 2018-12-05
Plain-language summary
This study aims to assess the efficacy of durvalumab in combination with radiochemotherapy (FOLFOX and IMRT) and then as maintenance therapy for treating patients with localised unresectable oesophageal cancer. This is a randomized, French national, multicentre, comparative phase II trial
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Histologically proven squamous cell carcinoma or adenocarcinoma of the oesophagus,
ā. Unresectable disease due to anatomical consideration or medical condition (patient unfit for surgical procedure),
ā. Presence of at least one measurable lesion \>10 mm with spiral CT scan,
ā. No prior therapy for pathology investigated including chemotherapy or radiotherapy prior to the study, except anterior out of field radiotherapy, received for treatment of another primary tumor considered in remission, in the past 5 years,
ā. Age ā„18 years old,
ā. WHO performance status \<2 (i.e., 0 or 1),
ā. Body weight \>35 kg,
ā. Life expectancy of at least 12 weeks ,
Exclusion criteria
ā. Previous treatment with another PD-1, PD-L1 including durvalumab or CTLA-4 inhibitor
ā. Metastatic disease,
ā. Patients should not receive live vaccine 30 days prior to study drug
ā. Female patients who are pregnant or breastfeeding
ā. Uncontrolled intercurrent illness including, but not limited to diabetes, hypertension, pulmonary failure, chronic renal or hepatic diseases, active peptic ulcer disease or gastritis, active bleeding, diatheses... (non-exhaustive list),
ā. Clinically significant cardiac disease or impaired cardiac function, such as:
ā. Congestive heart failure requiring treatment (New York Heart Association \[NYHA\] grade ā„2), left ventricular ejection fraction (LVEF) \<50% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO), or uncontrolled arterial hypertension defined by blood pressure \>140/100 mmHg at rest (average of 3 consecutive readings),
ā. History or current evidence of clinically significant cardiac arrhythmias, atrial fibrillation and/or conduction abnormality, e.g. congenital long QT syndrome, high- grade/complete AV-blockage,