Ignite Creation Date:
2024-05-06 @ 8:55 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02853474
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2016-07-06
Brief Title:
Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIC-1511
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
Detailed Description:
Medical oncology is aimed to increase patients survival even at metastatic stages in addition to disease-related and treatment-related symptoms However providing palliative care PC which includes symptoms management nutritional support psychosocial support as well as assistance on end-of-life preferences may be as important as survival issues to improve quality of life in such setting In France PC has been traditionally offered late at end-life stage although the World Health Organization recommends providing PC as earlier as possible in the course of the disease in order to increase quality of life
Decades ago PC services were initiated in France in order to provide a medical alternative to the use of questionable medical practices regarding the end of life period abandonment euthanasia and inappropriate aggressive therapy According to the French society of palliative care PC is an approach aimed to provide active care in a holistic approach to the person with a serious progressive or terminal illness The objective of PC is to relieve pain and other distressing symptoms but also to take into account the psychological social and spiritual suffering PC offers an interdisciplinary support system to help patients and their relatives As mentioned previously PC has been in France but also in the US usually offered late at end-life stage Actually PC access became a Right guaranteed by the Law for patients and their families in 1999 This context should explain why even nowadays PC often means end of life not only for the lay-man for the general public but also for caregivers and some doctors
The last World Health Organization WHO recommendations are far less restrictive than the 1996 French recommendations as it is stated that PC should be offered as earlier as possible in the course of the disease in order to increase quality of life and to positively influence the course of illness The World Health Organization recommendations add that PC is applicable early in the course of illness in conjunction with other therapies that are intended to prolong life such as chemotherapy or radiation therapy and includes those investigations needed to better understand and manage distressing clinical complications
In a recent randomized study 151 patients with newly diagnosed metastatic non-small-cell lung cancer were randomized to receive either early PC EPC combined with standard oncologic care or standard oncologic care alone It was hypothesized that patients who received EPC compared with patients who received standard oncologic care only would have a better quality of life primary endpoint The first visit with the PC service set up within the first 12 weeks and the median number of visits in the EPC group was 4 In this study the authors referred to the recommendations of the National Consensus Project for Quality Palliative Care Among patients with metastatic non-small-cell lung cancer EPC led to significant improvements in quality of life In addition EPC led to significant improvements in mood as well as in overall survival median survival 116 vs 89 months HR060 p 002 despite less aggressive end-of-life care
Following the publication of this American study the American Society of Clinical Oncology recommends nowadays that combined standard oncology care and PC should be considered earlier in the course of the illness for any patient with metastatic cancer However it is clear that a gap exists not only in France between this recommendation and the current practice In addition there is no consensus on how early PC should be integrated in oncologic services even though an underpowered small randomized trial reported recently an insignificant better survival favoring early versus delayed 3 months later initiation of PC
The results of the study described above although formally restricted to the field of metastatic non-small-cell lung cancers have modified the perception of many oncologists about the objectives of PC However additional clinical studies should be done before considering EPC as an additional survival input in other advanced malignancies
The median survival of metastatic upper gastrointestinal GI cancers such as pancreatic cancers gastric cancers and biliary tract cancers did not exceed 10-11 months which is as poor as reported with metastatic lung cancers Standard of care in the metastatic setting in upper GI cancers are described in ad hoc French guidelines ie Thésaurus National de Cancérologie Digestive Briefly standard of care in metastatic pancreatic cancer in the first-line setting lies on the combination of fluorouracil irinotecan and oxaliplatin FOLFIRINOX regimen for patients without any cholestasis and in good performance status and on gemcitabine monotherapy In metastatic biliary tract cancers standard of care lies on gemcitabine-based regimen gemcitabine monotherapy gemcitabine plus cisplatin or gemcitabine plus fluorouracil Besides HER2 positive metastatic gastricgastrooesophageal patients who present with much better prognosis and should be treated with trastuzumab-based regimen most of patients with metastatic gastricgastrooesophageal HER2 negative patients IHC or IHC with negative fishsish have poor prognosis with similar survival rates than patients with other upper GI malignancies In that setting several regimens may be offered to patients such as the following Folfox EOXECX Folfiri LV5FU2-cisplatin Capecitabine-platinum salt or docetaxel-based regimen Several experimental treatments antiangiogenics met inhibitors modulators of immune check points etc are currently tested in metastatic gastricgastrooesophageal cancers but these treatments are restricted to patients in good health condition who accept to participate to clinical trials and none of these trials have yet produced meaningful survival benefit in the first-line setting
To summarize therapeutic advances in the setting of metastatic upper GI cancers are infrequent and often modest Providing an extra survival benefit for these patients with EPC may contribute to deeply modify the practice of care of oncology in France
Decades ago PC services were initiated in France in order to provide a medical alternative to the use of questionable medical practices regarding the end of life period abandonment euthanasia and inappropriate aggressive therapy According to the French society of palliative care PC is an approach aimed to provide active care in a holistic approach to the person with a serious progressive or terminal illness The objective of PC is to relieve pain and other distressing symptoms but also to take into account the psychological social and spiritual suffering PC offers an interdisciplinary support system to help patients and their relatives As mentioned previously PC has been in France but also in the US usually offered late at end-life stage Actually PC access became a Right guaranteed by the Law for patients and their families in 1999 This context should explain why even nowadays PC often means end of life not only for the lay-man for the general public but also for caregivers and some doctors
The last World Health Organization WHO recommendations are far less restrictive than the 1996 French recommendations as it is stated that PC should be offered as earlier as possible in the course of the disease in order to increase quality of life and to positively influence the course of illness The World Health Organization recommendations add that PC is applicable early in the course of illness in conjunction with other therapies that are intended to prolong life such as chemotherapy or radiation therapy and includes those investigations needed to better understand and manage distressing clinical complications
In a recent randomized study 151 patients with newly diagnosed metastatic non-small-cell lung cancer were randomized to receive either early PC EPC combined with standard oncologic care or standard oncologic care alone It was hypothesized that patients who received EPC compared with patients who received standard oncologic care only would have a better quality of life primary endpoint The first visit with the PC service set up within the first 12 weeks and the median number of visits in the EPC group was 4 In this study the authors referred to the recommendations of the National Consensus Project for Quality Palliative Care Among patients with metastatic non-small-cell lung cancer EPC led to significant improvements in quality of life In addition EPC led to significant improvements in mood as well as in overall survival median survival 116 vs 89 months HR060 p 002 despite less aggressive end-of-life care
Following the publication of this American study the American Society of Clinical Oncology recommends nowadays that combined standard oncology care and PC should be considered earlier in the course of the illness for any patient with metastatic cancer However it is clear that a gap exists not only in France between this recommendation and the current practice In addition there is no consensus on how early PC should be integrated in oncologic services even though an underpowered small randomized trial reported recently an insignificant better survival favoring early versus delayed 3 months later initiation of PC
The results of the study described above although formally restricted to the field of metastatic non-small-cell lung cancers have modified the perception of many oncologists about the objectives of PC However additional clinical studies should be done before considering EPC as an additional survival input in other advanced malignancies
The median survival of metastatic upper gastrointestinal GI cancers such as pancreatic cancers gastric cancers and biliary tract cancers did not exceed 10-11 months which is as poor as reported with metastatic lung cancers Standard of care in the metastatic setting in upper GI cancers are described in ad hoc French guidelines ie Thésaurus National de Cancérologie Digestive Briefly standard of care in metastatic pancreatic cancer in the first-line setting lies on the combination of fluorouracil irinotecan and oxaliplatin FOLFIRINOX regimen for patients without any cholestasis and in good performance status and on gemcitabine monotherapy In metastatic biliary tract cancers standard of care lies on gemcitabine-based regimen gemcitabine monotherapy gemcitabine plus cisplatin or gemcitabine plus fluorouracil Besides HER2 positive metastatic gastricgastrooesophageal patients who present with much better prognosis and should be treated with trastuzumab-based regimen most of patients with metastatic gastricgastrooesophageal HER2 negative patients IHC or IHC with negative fishsish have poor prognosis with similar survival rates than patients with other upper GI malignancies In that setting several regimens may be offered to patients such as the following Folfox EOXECX Folfiri LV5FU2-cisplatin Capecitabine-platinum salt or docetaxel-based regimen Several experimental treatments antiangiogenics met inhibitors modulators of immune check points etc are currently tested in metastatic gastricgastrooesophageal cancers but these treatments are restricted to patients in good health condition who accept to participate to clinical trials and none of these trials have yet produced meaningful survival benefit in the first-line setting
To summarize therapeutic advances in the setting of metastatic upper GI cancers are infrequent and often modest Providing an extra survival benefit for these patients with EPC may contribute to deeply modify the practice of care of oncology in France
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-A01943-46 | OTHER | ANSM | None |