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Oncology
Protocol
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
  1. Emilie Hutt1,
  2. Arlette Da Silva2,
  3. Emilie Bogart3,
  4. Sara Le Lay-Diomande4,
  5. Diane Pannier1,
  6. Stéphanie Delaine-Clisant4,
  7. Marie-Cécile Le Deley3,5,
  8. Antoine Adenis1,6
  1. 1 Department of Gastrointestinal Oncology, Centre Oscar Lambret, Lille, France
  2. 2 Palliative Care Unit, Centre Oscar Lambret, Lille, France
  3. 3 Methodology and Biostatistic Unit, Centre Oscar Lambret, Lille, France
  4. 4 Clinical Research Unit, Centre Oscar Lambret, Lille, France
  5. 5 CESP, INSERM, Faculté de médecine, Université Paris-Sud, Université Paris-Saclay, Villejuif, France
  6. 6 Catholic University, Lille, France
  1. Correspondence to Professor Antoine Adenis; scientifique{at}o-lambret.fr

Abstract

Introduction Palliative care (PC) has usually been offered at the end-of-life stage, although the WHO recommends providing PC as early as possible in the course of the disease. A recent study has shown that early PC (EPC) provides a more meaningful effect on quality of life and, surprisingly, on overall survival (OS) than standard treatment for patients with metastatic lung cancer. Whether EPC benefits also apply to patients with metastatic upper gastrointestinal (GI) cancers is unknown.

Methods and analysis EPIC is a randomised phase III trial comparing EPC plus standard oncologic care versus standard oncologic care in patients with metastatic upper GI cancers. Its primary objective is to evaluate the efficacy of EPC in terms of OS. Its secondary objectives are to assess the effects of EPC on patient-reported outcomes (quality of life, depression and anxiety) and the effect of EPC on the number of patients receiving chemotherapy in their last 30 days of life. Assuming an exponential distribution of survival time, 381 deaths are required to ensure an 80% power for an absolute difference of 10% in 1 year OS rates (40% vs 50.3%, HR=0.75; log rank test two-sided alpha=5%), leading to a planned sample size of 480 patients enrolled over 3 years and a final analysis at 4 years. The main analysis will be performed on the intent-to-treat dataset.

Ethics and dissemination This study was approved by the ‘Comité de Protection des Personnes Nord-Ouest I’ (4 April 2016), complies with the Helsinki declaration and French laws and regulations and follows the International Conference on Harmonisation E6 (R1) Guideline for Good Clinical Practice. The trial results, even if they are inconclusive, will be presented at international oncology congresses and published in peer-reviewed journals.

Trial registration numbers EudraCT: 2015-A01943-46; Pre-results. NCT02853474.

  • gastrointestinal cancer
  • palliative care
  • randomized trial

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-015904

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    Footnotes

    • Contributors AA, ADS, EH and M-CLD designed the study and will contribute to data interpretation. AA, ADS, M-CLD, EH and SLL-D contributed to the drafting of the manuscript. AA, EH and SLL-D contributed to the trial set-up. SLL-D is responsible for data collection and for administrative support. EB will contribute to statistical analysis. M-CLD is responsible for data management and statistical analysis. All authors contributed to the revision of the manuscript and approved it for submission.

    • Funding This study is supported by unrestricted public grants from Conseil Régional du Nord Pas-de-Calais and from caregivers Ligue National contre le Cancer. The funders have no role in study design, management, analysis and interpretation of data as well as no role in the writing of the final report.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval (CPP Nord-Ouest I, 4 April 2016).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement This manuscript contains original material without any unpublished data, but the full results of this ongoing trial.

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