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

NCT02853474 | Completed Phase 3

• 2 other identifiers: EPIC-15112015-A01943-46
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 20

Brief 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).

Conditions

Gastric Cancer; Pancreas Cancer; Bile Duct Cancer; Gastroesophageal Cancer; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (as intent-to treat analysis)

  The overall survival is defined as the time between the date of randomization and the date of death, whatever the cause.

  An average of 1 year

Secondary Outcomes (8)

• Overall survival (per protocol analysis)

  An average of 1 year

• One year survival rate (intent-to treat and per protocol analyses)

  1 year

• Quality of life assessed with the QLQ-C30

  every 8 weeks until the patient withdrawal from the study (during an average of 1 year)

• Depression assessed with the HADS score

  every 8 weeks during 24 weeks

• TUDD (Time Until Definitive Deterioration)

  An average of 1 year

Study Arms (2)

Arm A: Chemotherapy (CT) alone

SHAM COMPARATOR

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

Other: EORTC-QLQ-C30 questionnaire; Other: HADS score

Arm B: CT + Early Palliative care(EPC)

EXPERIMENTAL

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

Behavioral: Early Palliative Care visit; Other: EORTC-QLQ-C30 questionnaire; Other: HADS score

Interventions

Early Palliative Care visit BEHAVIORAL

A PC visit is a visit done by a PC physician. Any kind of visits done by other professionals IS NOT a PC visit. Five PC visits are scheduled in this arm.

Arm B: CT + Early Palliative care(EPC)

EORTC-QLQ-C30 questionnaire OTHER

The Quality of Life is assessed with the QLQ-C30 questionnaire at baseline, 12 and 24 weeks after inclusion, as well as every 8 weeks thereafter.

Arm A: Chemotherapy (CT) alone; Arm B: CT + Early Palliative care(EPC)

HADS score OTHER

The depression is assessed with the HADS scale (Hospital Anxiety and Depression Scale) at baseline, and then 12 and 24 weeks after inclusion.

Arm A: Chemotherapy (CT) alone; Arm B: CT + Early Palliative care(EPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Ligue contre le cancer, France: collaborator
• Région Nord-Pas de Calais, France: collaborator
• National Cancer Institute, France: collaborator

Study Sites (20)

Institut de cancérologie de l'Ouest-site PAUL

Angers, France

Location

CH de Béthune

Beuvry, 62660, France

Location

Centre Hospitalier Boulogne sur Mer

Boulogne-sur-Mer, 62200, France

Location

Centre François Baclesse, Caen

Caen, France

Location

Centre Georges Francois Leclerc de DIJON

Dijon, 21000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Hôpital Saint Vincent de Paul

Lille, 59020, France

Location

CHRU, Hôpital Claude HURIEZ

Lille, 59037, France

Location

Centre Léon Bérard de LYON

Lyon, 69373, France

Location

Institut Paoli-Calmettes de MARSEILLE

Marseille, France

Location

Institut du Cancer de Montpellier

Montpellier, France

Location

Institut de cancérologie de Lorraine, Nancy

Nancy, France

Location

Institut de cancérologie de l'Ouest, Nantes

Nantes, France

Location

Centre Antoine LACASSAGNE DE NICE

Nice, 06100, France

Location

Institut Curie, site de Saint Cloud, Hopital

Saint-Cloud, France

Location

CHU de Nantes, CHU - hôpital Nord Laennec,

Saint-Herblain, 44800, France

Location

Centre Hospitalier Universitaire de STRASBOURG

Strasbourg, France

Location

Centre Paul Strauss, Strasbourg

Strasbourg, France

Location

Centre Hospitalier de Tourcoing

Tourcoing, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 59322, France

Location

Related Publications (2)

• Adenis 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 DERIVED

• Hutt 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 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms; Bile Duct Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Officials

• Arlette Da Silva, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

• Antoine Adenis, MD, PhD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: August 3, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)