Clinical trial · Interventional
Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy
Impact of Early Palliative Care on Overall Survival of Patients With Metastatic Upper Gastrointestinal Cancers, Treated With First-line Chemotherapy: a Randomized Phase III Trial
NCT02853474CI-TRIAL-00065975EPIC-1511completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Cancer | — | UNRESOLVED | — |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early Palliative Care visit | Behavioral | — | UNRESOLVED |
| EORTC-QLQ-C30 questionnaire | Other | — | UNRESOLVED |
| HADS score | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Arm A: Chemotherapy (CT) alone
- description
- 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
- interventionNames
- Other: EORTC-QLQ-C30 questionnaire
- Other: HADS score
- type
- EXPERIMENTAL
- label
- Arm B: CT + Early Palliative care(EPC)
- description
- 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
- interventionNames
- Behavioral: Early Palliative Care visit
- Other: EORTC-QLQ-C30 questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDAdenis A, Da Silva A, Ben Abdelghani M, Bourgeois V, Bogart E, Turpin A, Evin A, Proux A, Galais MP, Jaraudias C, Quintin J, Bouquet G, Samalin E, Bremaud N, Javed S, Henry A, Kurtz JE, Cornuault-Foubert D, Vandamme H, Lucchi E, Pannier D, Belletier C, Paul M, Touzet L, Penel N, Chvetzoff G, Le Deley MC. Early palliative care and overall survival in patients with metastatic upper gastrointestinal cancers (EPIC): a multicentre, open-label, randomised controlled phase 3 trial. EClinicalMedicine. 2024 Jun 28;74:102470. doi: 10.1016/j.eclinm.2024.102470. eCollection 2024 Aug. PMID 39526177
- DERIVEDHutt E, Da Silva A, Bogart E, Le Lay-Diomande S, Pannier D, Delaine-Clisant S, Le Deley MC, Adenis A. Impact of early palliative care on overall survival of patients with metastatic upper gastrointestinal cancers treated with first-line chemotherapy: a randomised phase III trial. BMJ Open. 2018 Jan 23;8(1):e015904. doi: 10.1136/bmjopen-2017-015904. PMID 29362244