Gastric Cancer Clinical Trial
— EPIC-1511Official 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
Verified date | April 2023 |
Source | Centre Oscar Lambret |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 480 |
Est. completion date | December 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Institut de cancérologie de l'Ouest-site PAUL | Angers | |
France | CH de Béthune | Beuvry | |
France | Centre Hospitalier Boulogne sur Mer | Boulogne sur Mer | |
France | Centre François Baclesse, Caen | Caen | |
France | Centre Georges Francois Leclerc de DIJON | Dijon | |
France | Centre Oscar Lambret | Lille | |
France | CHRU, Hôpital Claude HURIEZ | Lille | |
France | Hôpital Saint Vincent de Paul | Lille | |
France | Centre Léon Bérard de LYON | Lyon | |
France | Institut Paoli-Calmettes de MARSEILLE | Marseille | |
France | Institut du Cancer de Montpellier | Montpellier | |
France | Institut de cancérologie de Lorraine, Nancy | Nancy | |
France | Institut de cancérologie de l'Ouest, Nantes | Nantes | |
France | Centre Antoine LACASSAGNE DE NICE | Nice | |
France | Institut Curie, site de Saint Cloud, Hopital | Saint Cloud | |
France | CHU de Nantes, CHU - hôpital Nord Laennec, | Saint-Herblain | |
France | Centre Hospitalier Universitaire de STRASBOURG | Strasbourg | |
France | Centre Paul Strauss, Strasbourg | Strasbourg | |
France | Centre Hospitalier de Tourcoing | Tourcoing | |
France | Centre Hospitalier de Valenciennes | Valenciennes |
Lead Sponsor | Collaborator |
---|---|
Centre Oscar Lambret | Ligue contre le cancer, France, National Cancer Institute, France, Région Nord-Pas de Calais, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Overall survival (per protocol analysis) | Overall survival curves in per protocol analysis will be given. | An average of 1 year | |
Secondary | One year survival rate (intent-to treat and per protocol analyses) | One year survival rates with their 95% confidence interval in both intent-to-treat and per protocol analyses | 1 year | |
Secondary | Quality of life assessed with the QLQ-C30 | 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. | every 8 weeks until the patient withdrawal from the study (during an average of 1 year) | |
Secondary | Depression assessed with the HADS score | The depression is assessed with the HADS scale (Hospital Anxiety and Depression Scale) at baseline, and after inclusion, every 8 weeks during 24 weeks. | every 8 weeks during 24 weeks | |
Secondary | TUDD (Time Until Definitive Deterioration) | 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. | An average of 1 year | |
Secondary | Presence or lack of advanced directives | The number of patients whom advanced directives are written in their medical records will be recorded. | through study completion, an average of 1 year | |
Secondary | Questionnaire "content of PC visits" | 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. |
during the 6 first months after randomization | |
Secondary | Number of patients treated with chemotherapy | The number of patients treated with chemotherapy in their 30 last days before death will be recorded. | 30 days before death of the patient |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05551416 -
The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
|
||
Completed |
NCT05518929 -
Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients
|
Phase 4 | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03219593 -
Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT05536102 -
The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Active, not recruiting |
NCT04082364 -
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
|
Phase 2/Phase 3 | |
Withdrawn |
NCT03766607 -
Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT01924533 -
Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
|
Phase 3 | |
Terminated |
NCT01641939 -
A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
Active, not recruiting |
NCT04908813 -
Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04249739 -
Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive
|
Phase 2 | |
Recruiting |
NCT05514158 -
To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG)
|
Phase 1 | |
Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 |