Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy (EPIC-1511)
Gastric Cancer, Pancreas Cancer, Bile Duct Cancer
About this trial
This is an interventional supportive care trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with an upper gastrointestinal metastatic cancer: pancreatic, biliary tract, esophageal or gastric (including junctional Siewert 2 and 3 cancers) cancers.
NB: gastrooesophageal junctional cancers with dysphagia and/or gastric/gastrooesophageal cancers with unknown or positive HER2 status are not eligible.
- Patients planed to be treated with first-line chemotherapy for metastatic disease.
- Age ≥ 18 years
- Life expectancy ≥ 1 month
- Performance status (OMS) ≤ 2
- Good understanding of French language
- Signed and dated informed consent
- Patients covered by government health insurance
Exclusion Criteria:
- Locally advanced cancer
- Junctional Siewert 1 gastrooesophageal cancer
- Gastric or junctional gastrooesophageal cancer with dysphagia (Atkinson>2)
- Gastric or junctional gastrooesophageal cancer with unknown or positive HER2 status (IHC: +++ or IHC ++ and FISH/SISH +)
- Compression of the biliary tract requiring a bypass
Sites / Locations
- Institut de cancérologie de l'Ouest-site PAUL
- CH de Béthune
- Centre Hospitalier Boulogne sur Mer
- Centre François Baclesse, Caen
- Centre Georges Francois Leclerc de DIJON
- Centre Oscar Lambret
- Hôpital Saint Vincent de Paul
- CHRU, Hôpital Claude HURIEZ
- Centre Léon Bérard de LYON
- Institut Paoli-Calmettes de MARSEILLE
- Institut du Cancer de Montpellier
- Institut de cancérologie de Lorraine, Nancy
- Institut de cancérologie de l'Ouest, Nantes
- Centre Antoine LACASSAGNE DE NICE
- Institut Curie, site de Saint Cloud, Hopital
- CHU de Nantes, CHU - hôpital Nord Laennec,
- Centre Hospitalier Universitaire de STRASBOURG
- Centre Paul Strauss, Strasbourg
- Centre Hospitalier de Tourcoing
- Centre Hospitalier de Valenciennes
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Arm A: Chemotherapy (CT) alone
Arm B: CT + Early Palliative care(EPC)
The medical oncologists (or gastro enterologist physician) are in charge of the patient for CT administration, and for the management of symptoms related to the disease and/or the treatment, in accordance with professional practices. If needed (any time), a PC (Palliative consultation) visit could be performed. Interventions are : EORTC-QLQ-C30 questionnaire for the assessment of quality of life HADS score for anxiety and depression assessment
Standard oncology care as for arm A plus early PC visits. Interventions are : EORTC-QLQ-C30 questionnaire for the assessment of quality of life HADS score for anxiety and depression assessment Early palliative care visits