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Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy (EPIC-1511)

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ClinicalTrials.gov Identifier: NCT02853474
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : July 3, 2019
Sponsor:
Collaborators:
Ligue contre le cancer, France
Région Nord-Pas de Calais, France
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret

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).

Condition or disease Intervention/treatment Phase
Gastric Cancer Pancreas Cancer Bile Duct Cancer Gastroesophageal Cancer Esophageal Cancer Behavioral: Early Palliative Care visit Other: EORTC-QLQ-C30 questionnaire Other: HADS score Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022


Arm Intervention/treatment
Sham Comparator: Arm A: Chemotherapy (CT) alone

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
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.

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

Experimental: Arm B: CT + Early Palliative care(EPC)

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

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.


Other: EORTC-QLQ-C30 questionnaire
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.

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




Primary Outcome Measures :
  1. Overall survival (as intent-to treat analysis) [ Time Frame: An average of 1 year ]
    The overall survival is defined as the time between the date of randomization and the date of death, whatever the cause.


Secondary Outcome Measures :
  1. Overall survival (per protocol analysis) [ Time Frame: An average of 1 year ]
    Overall survival curves in per protocol analysis will be given.

  2. One year survival rate (intent-to treat and per protocol analyses) [ Time Frame: 1 year ]
    One year survival rates with their 95% confidence interval in both intent-to-treat and per protocol analyses

  3. Quality of life assessed with the QLQ-C30 [ Time Frame: every 8 weeks until the patient withdrawal from the study (during an average of 1 year) ]
    The Quality of Life is assessed with the QLQ-C30 questionnaire at baseline, and after inclusion, every 8 weeks until patient withdrawal from the study.

  4. Depression assessed with the HADS score [ Time Frame: every 8 weeks during 24 weeks ]
    The depression is assessed with the HADS scale (Hospital Anxiety and Depression Scale) at baseline, and after inclusion, every 8 weeks during 24 weeks.

  5. TUDD (Time Until Definitive Deterioration) [ Time Frame: An average of 1 year ]
    TUDD for Quality of Life scores was defined as the time from randomization to the first observation of a definitive deterioration of QLQ-C30 score or death.

  6. Presence or lack of advanced directives [ Time Frame: through study completion, an average of 1 year ]
    The number of patients whom advanced directives are written in their medical records will be recorded.

  7. Questionnaire "content of PC visits" [ Time Frame: during the 6 first months after randomization ]

    A PC visit is a visit done by a PC physician. Any kind of visits done by other professionals (i.e: dieticians, nurses, social workers, psychologists, pain specialists, etc.) IS NOT a PC visit.

    In Arm B (interventional arm), the content of each PC visit will be described by the PC physician at the end of the visit, by filling a specific check-list built by an ad hoc working-group of PC physicians.


  8. Number of patients treated with chemotherapy [ Time Frame: 30 days before death of the patient ]
    The number of patients treated with chemotherapy in their 30 last days before death will be recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853474


Contacts
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Contact: Marie Vanseymortier, Pharm.D. +33 (0) 3 20 29 59 18 promotion@o-lambret.fr
Contact: Arlette Da Silva, MD (33)3 20 29 59 18 a-dasilva@o-lambret.fr

Locations
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France
Institut de cancérologie de l'Ouest-site PAUL Recruiting
Angers, France
Contact: Delphine CORNUAULT FOUBERT, MD       delphine.cornuault-foubert@ico.unicancer.fr   
CH de Béthune Not yet recruiting
Beuvry, France, 62660
Contact: Hélène VAN DAMME, MD    03 21 64 43 19    hvandamme@ch-bethune.fr   
Centre Hospitalier Boulogne sur Mer Recruiting
Boulogne sur Mer, France, 62200
Contact: Vincent BOURGEOIS, MD    03 21 99 32 41      
Centre François Baclesse, Caen Recruiting
Caen, France
Contact: Marie-Pierre GALAIS, MD       mpgalais@balcesse.unicancer.fr   
Centre Georges Francois Leclerc de DIJON Not yet recruiting
Dijon, France, 21000
Contact: Francois Ghiringhelli, md    03 80 73 75 00    FGhiringhelli@cgfl.fr   
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Antoine ADENIS, MD, PhD    (33)3 20 29 59 18      
Contact: Arlette Da Silva, MD    (33)3 20 29 59 18    a-dasilva@o-lambret.fr   
Hôpital Saint Vincent de Paul Recruiting
Lille, France, 59020
Contact: Charlotte PEUGNIEZ, MD    03 20 87 45 32    peugniez.charlotte@ghicl.net   
CHRU, Hôpital Claude HURIEZ Recruiting
Lille, France, 59037
Contact: Mohamed HEBBAR, MD, PhD    59037    mohamed.hebbar@chru-lille.fr   
Centre Léon Bérard de LYON Not yet recruiting
Lyon, France, 69373
Contact: Gisèle CHVETZOFF, MD    04 78 78 26 57    gisele.chvetzoff@lyon.unicancer.fr   
Institut Paoli-Calmettes de MARSEILLE Recruiting
Marseille, France
Contact: Geraldine CAPODANO, MD    04 91 22 33 33    CAPODANOG@ipc.unicancer.fr   
Institut du Cancer de Montpellier Recruiting
Montpellier, France
Contact: Emmanuelle SAMALIN, MD       Emmanuelle.Samalin@icm.unicancer.fr   
Institut de cancérologie de Lorraine, Nancy Recruiting
Nancy, France
Contact: Aline HENRY, MD       a.henry@nancy.unicancer.fr   
Institut de cancérologie de l'Ouest, Nantes Recruiting
Nantes, France
Contact: Julia QUINTIN, MD       julia.quintin@ico.unicancer.fr   
Centre Antoine LACASSAGNE DE NICE Recruiting
Nice, France, 06100
Contact: Eric François, MD    04 92 03 16 13    eric.francois@nice.unicancer.fr   
Institut Curie, site de Saint Cloud, Hopital Recruiting
Saint Cloud, France
Contact: Elisabeth ANGELLIER, MD    01 47 11 23 80    elisabeth.angelier@curie.fr   
CHU de Nantes, CHU - hôpital Nord Laennec, Recruiting
Saint-Herblain, France, 44800
Contact: Adrien EVIN, MD    02 53 48 27 36    Adrien.EVIN@chu-nantes.fr   
Centre Hospitalier Universitaire de STRASBOURG Recruiting
Strasbourg, France
Contact: Jean Emmanuel KURTZ, MD, PhD    03 88 12 76 82    j-emmanuel.kurtz@chru-strasbourg.fr   
Centre Paul Strauss, Strasbourg Recruiting
Strasbourg, France
Contact: Meher BEN ABDELGHANI, MD       mbenabdelghani@strasbourg.unicancer.fr   
Centre Hospitalier de Tourcoing Recruiting
Tourcoing, France
Contact: Guillaume BOUQUET, MD       g-bouquet@ch-tourcoing.fr   
Centre Hospitalier de Valenciennes Recruiting
Valenciennes, France, 59322
Contact: Isabelle BONNET    03 27 14 05 40    bonnet-i@ch-valenciennes.fr   
Contact: , MD         
Sponsors and Collaborators
Centre Oscar Lambret
Ligue contre le cancer, France
Région Nord-Pas de Calais, France
National Cancer Institute, France
Investigators
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Principal Investigator: Arlette Da Silva, MD Centre Oscar Lambret
Principal Investigator: Antoine Adenis, MD, PhD Centre Oscar Lambret

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02853474     History of Changes
Other Study ID Numbers: EPIC-1511
2015-A01943-46 ( Other Identifier: ANSM )
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases