CompletedPhase 3

Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy

France480 participantsStarted 2016-10

Plain-language summary

This prospective, randomized, open-label and multicenter phase III study is aimed to estimate the survival benefit of Early Palliative Care (EPC) combined with standard oncology care including first-line chemotherapy (experimental arm) over standard oncology care only (standard arm), in patients with metastatic upper gastrointestinal cancers (gastric cancer, pancreatic cancer, biliary tract cancers).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Overall survival (as intent-to treat analysis)

Timeframe: An average of 1 year

Trial details

NCT IDNCT02853474

SponsorCentre Oscar Lambret

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12