Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal … (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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically proven squamous cell carcinoma or adenocarcinoma of the oesophagus,
. Unresectable disease due to anatomical consideration or medical condition (patient unfit for surgical procedure),
. Presence of at least one measurable lesion \>10 mm with spiral CT scan,
. 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,
. Age ≥18 years old,
. WHO performance status \<2 (i.e., 0 or 1),
. Body weight \>35 kg,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Previous treatment with another PD-1, PD-L1 including durvalumab or CTLA-4 inhibitor
. Metastatic disease,
. Patients should not receive live vaccine 30 days prior to study drug
. Female patients who are pregnant or breastfeeding
. 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),
. Clinically significant cardiac disease or impaired cardiac function, such as:
. Congestive heart failure requiring treatment (New York Heart Association \[NYHA\] grade ≥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),
. 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,