Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence (VESTIGE)
Primary Purpose
Gastric and Esophagogastric Junction Adenocarcinoma
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab and Ipilimumab
chemotherapy
Sponsored by

About this trial
This is an interventional treatment trial for Gastric and Esophagogastric Junction Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Histologically proven gastric, lower esophageal or GE-junction adenocarcinoma (Siewert I-III)
- Subjects must have completed pre-operative chemotherapy with a fluoropyrimidine-platinum containing regimen and macroscopically complete surgery prior to randomization
- Minimal duration of neoadjuvant chemotherapy should be 6 weeks, maximum 12 weeks.
- Total or distal gastrectomy with D2 lymphadenectomy according to ESMO guidelines should have been completed for gastric and junctional Siewert type III cancers. Ivor Lewis or McKeown oesophagectomy with two field lymphadenectomy should have been performed for junctional Siewert type I cancers. For Siewert type II cancers either total gastrectomy with D2-lymphadenectomy or oesophagectomy with two field lymphadenectomy should have been completed. Open, minimal invasive or hybrid surgical approaches are acceptable as long as the requirements above are fulfilled.
- Regardless of the type of surgery a minimum of 15 lymph nodes should have been resected and examined.
- Recovered from surgery and fit for study treatment as assessed by a multidisciplinary team. Surgery should have been completed 2 to 3 months before randomization.
- ypN1-3 status according to current (8th) version of TNM classification system. In case of an ypN0 status patients must meet the inclusion criterion of R1 resection.
- R0 or R1 resection according to current (8th) version of TNM classification system. In case of R0 resection, patients must meet the inclusion criterion of ypN1-3
- WHO performance status score of 0 or 1
- Age ≥ 18 years
- Adequate organ function assessed within 7 days before randomization:
- White blood cell count (WBC) > 2 x 109/L
- Absolute neutrophil count (ANC) > 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin ≥ 9 g/dL
- Measured/calculated creatinine clearance ≥ 60 mL/min (according to Cockroft-Gault formula).
- Total bilirubin within normal limits (if the patient has documented Gilbert's disease ≤ 1.5 * ULN or direct bilirubin ≤ ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5ULN
- Cardiac assessment by 12 Lead ECG and if clinically indicated, cardiac function assessment (using either echocardiography or MUGA scan)
- All toxicities (exception alopecia) attributed to prior anti-cancer therapy must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug.
- Women of childbearing potential (WOCBP*) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within 24 hours prior to randomization
- Men who are sexually active with an WOCBP must adhere to contraception (condom) during the study and for a period of 7 months after the last dose of the study treatment in the experimental arm and 6 months in the control arm.
- Patients of childbearing / reproductive potential should use highly effective method of birth control measures during the study treatment period and for at least 5 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
- Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion Criteria:
- R2 resection status
- M1 stage according to current (8th) version of TNM classification system
- Patients who have undergone complete resection of metastases
- Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for postoperative chemotherapy or immunotherapy
- Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina pectoris, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious cardiac arrhythmia requiring medication
- Subjects with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry. Adequately treated cervical carcinoma in situ, and localized non-melanoma skin cancer are no exclusion criteria, regardless of timepoint of diagnosis.
- Subjects with active, known, or suspected infectious or autoimmune disease
- Patients who have received antibiotics within the last 14 days before randomization are excluded.
- Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll
- Subjects with a condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration
- Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- Subjects with > Grade 1 peripheral neuropathy
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Prior or concomitant treatment with radiotherapy/radiochemotherapy
- Any positive test result for HBV or HCV indicating acute or chronic infection
- Known history of HIV or known AIDS and, if required by local practice or positive HIV testing at screening
- Known uncontrollable hypersensitivity to the components of cisplatin/oxaliplatin, fluorouracil (5-FU) or capecitabine, epirubicine or docetaxel
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Ongoing or concomitant use of the antiviral drug sorivudine or its chemically related analogs, such as brivudine.
Sites / Locations
- Masaryk Memorial Cancer Institute
- University Hospital Hradec Kralove
- CHRU de Lille - Hopital Huriez
- Hôpital Privé Jean Mermoz
- Gustave Roussy
- Charite - Universitaetsmedizin Berlin
- Kliniken Essen-Mitte
- Universitaetsklinikum Freiburg
- Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
- SLK-Kliniken Heilbronn
- Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden
- Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar
- Universitaetsklinikum Tuebingen-Uni Kliniken Berg
- Rambam Health Care Campus, Oncology Institute
- Rabbin Medical Centre - Tel Aviv
- Azienda Ospedaliera a Papa Giovanni XXIII
- Istituto Europeo di Oncologia
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
- Oslo University Hospital - Ullevaal Hospital
- Maria Sklodowska-Curie Memorial Cancer Centre
- Institut Catalan d'Oncologia - ICO Badalona
- Hospital Universitario 12 de Octubre
- Complejo Hospitalario A
- Hospital Clinico Universitario de Valencia
- Cambridge University Hospital NHS
- Royal Marsden Hospital
- University College London Hospitals NHS Foundation Trust
- Royal Marsden Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
chemotherapy arm
immunotherapy arm
Arm Description
Completion of the perioperative treatment according to the 2016 ESMO guidelines (change of regimen is not allowed).
Treatment: Nivolumab 1 mg/kg IV Q3W plus Ipilimumab 3 mg/kg IV Q3W for 4 cycles (3 months) followed by nivolumab 240 mg flat-dose IV Q2W for 9 months.Total treatment time 1 year. No chemotherapy.
Outcomes
Primary Outcome Measures
Disease free survival (DFS)
Disease free survival is defined as the time interval between randomization and the date of disease recurrence or death from any cause, whichever comes first. Patients alive with no disease recurrence are censored at the date of the last follow-up examination. randomization and the date of disease recurrence or death from any cause, whichever comes first.
Secondary Outcome Measures
Overall survival (OS)
Overall survival is defined as the time interval between the date of randomization and the date of death from any cause. Patients who are still alive when last traced are censored at the date of last follow up.
Loco-regional failure rates
Local recurrence is defined as evidence of tumor in the anastomotic area. Regional recurrence is defined as evidence of tumor in the locoregional lymph nodes or other surrounding structures apart from the anastomotic site. Death in absence of loco-regional failure will be considered as a competing risk in the estimation of the cumulative incidence of loco-regional failures. Patients who have not had any such event at the time of data analysis will be censored at the date of the last follow-up examination.
Distant failure rates
The diagnosis of distant recurrence requires imaging confirmed by pathology. Once recurrence is confirmed, the date of recurrence is the first date when recurrence was suspected.
Distant recurrence is defined as recurrence not considered as local or regional.Death in absence of distant failure will be considered as a competing risk in the estimation of the cumulative incidence of distant failures. Patients who have not had any such event at the time of data analysis will be censored at the date of the last follow-up examination
Rate of adverse events according to NCI-CTCAE
All adverse events will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events. AEs will be collected at baseline from randomization.
Only the worst grade per CTCAE category will be recorded per cycle. All adverse events must be followed until resolution or stabilization. Adverse Events of Special Interest for ipilimumab and nivolumab requiring a close follow-up were identified as a result of signals observed from previous studies involving the protocol treatments. These events require a close follow-up
Quality of life assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3
Quality of life will be assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3. These include five functional scales (physical, role, emotional, social, and cognitive), three symptom (fatigue, nausea and vomiting and pain) and a global health status/QoL scale and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). The primary HRQoL endpoints that are considered relevant for this study are global health status/QoL and physical functioning.A difference of 10 points on the 100-point QLQ-C30 scale between the two arms will be considered as clinically relevant
Full Information
NCT ID
NCT03443856
First Posted
February 19, 2018
Last Updated
September 6, 2023
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
1. Study Identification
Unique Protocol Identification Number
NCT03443856
Brief Title
Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence
Acronym
VESTIGE
Official Title
Adjuvant Immunotherapy in Patients With Resected Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): an Open Label Randomized Controlled Phase-2-study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection.
Other study objectives:
To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the study
To correlate nutritional status assessment on outcomes and quality of life of patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric and Esophagogastric Junction Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chemotherapy arm
Arm Type
Other
Arm Description
Completion of the perioperative treatment according to the 2016 ESMO guidelines (change of regimen is not allowed).
Arm Title
immunotherapy arm
Arm Type
Experimental
Arm Description
Treatment: Nivolumab 1 mg/kg IV Q3W plus Ipilimumab 3 mg/kg IV Q3W for 4 cycles (3 months) followed by nivolumab 240 mg flat-dose IV Q2W for 9 months.Total treatment time 1 year. No chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Nivolumab and Ipilimumab
Intervention Description
Nivolumab 1 mg/kg IV Q3W plus Ipilimumab 3 mg/kg IV Q3W for 4 cycles (3 months) followed by nivolumab 240 mg flat-dose IV Q2W for 9 months.Total treatment time 1 year
Intervention Type
Other
Intervention Name(s)
chemotherapy
Intervention Description
Completion of the perioperative treatment according to the 2016 ESMO guidelines (change of regimen is not allowed).
Primary Outcome Measure Information:
Title
Disease free survival (DFS)
Description
Disease free survival is defined as the time interval between randomization and the date of disease recurrence or death from any cause, whichever comes first. Patients alive with no disease recurrence are censored at the date of the last follow-up examination. randomization and the date of disease recurrence or death from any cause, whichever comes first.
Time Frame
22 months after last patient in
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival is defined as the time interval between the date of randomization and the date of death from any cause. Patients who are still alive when last traced are censored at the date of last follow up.
Time Frame
5 years after last patient in
Title
Loco-regional failure rates
Description
Local recurrence is defined as evidence of tumor in the anastomotic area. Regional recurrence is defined as evidence of tumor in the locoregional lymph nodes or other surrounding structures apart from the anastomotic site. Death in absence of loco-regional failure will be considered as a competing risk in the estimation of the cumulative incidence of loco-regional failures. Patients who have not had any such event at the time of data analysis will be censored at the date of the last follow-up examination.
Time Frame
5 years after last patient in
Title
Distant failure rates
Description
The diagnosis of distant recurrence requires imaging confirmed by pathology. Once recurrence is confirmed, the date of recurrence is the first date when recurrence was suspected.
Distant recurrence is defined as recurrence not considered as local or regional.Death in absence of distant failure will be considered as a competing risk in the estimation of the cumulative incidence of distant failures. Patients who have not had any such event at the time of data analysis will be censored at the date of the last follow-up examination
Time Frame
5 years after last patient in
Title
Rate of adverse events according to NCI-CTCAE
Description
All adverse events will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events. AEs will be collected at baseline from randomization.
Only the worst grade per CTCAE category will be recorded per cycle. All adverse events must be followed until resolution or stabilization. Adverse Events of Special Interest for ipilimumab and nivolumab requiring a close follow-up were identified as a result of signals observed from previous studies involving the protocol treatments. These events require a close follow-up
Time Frame
5 years after last patient in
Title
Quality of life assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3
Description
Quality of life will be assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3. These include five functional scales (physical, role, emotional, social, and cognitive), three symptom (fatigue, nausea and vomiting and pain) and a global health status/QoL scale and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). The primary HRQoL endpoints that are considered relevant for this study are global health status/QoL and physical functioning.A difference of 10 points on the 100-point QLQ-C30 scale between the two arms will be considered as clinically relevant
Time Frame
questionnaires will be completed at baseline, week 6, 3 months, 6 months, 9 months, 12 months, 15 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven gastric, lower esophageal or GE-junction adenocarcinoma (Siewert I-III)
Subjects must have completed pre-operative chemotherapy with a fluoropyrimidine-platinum containing regimen and macroscopically complete surgery prior to randomization
Minimal duration of neoadjuvant chemotherapy should be 6 weeks, maximum 12 weeks.
Total or distal gastrectomy with D2 lymphadenectomy according to ESMO guidelines should have been completed for gastric and junctional Siewert type III cancers. Ivor Lewis or McKeown oesophagectomy with two field lymphadenectomy should have been performed for junctional Siewert type I cancers. For Siewert type II cancers either total gastrectomy with D2-lymphadenectomy or oesophagectomy with two field lymphadenectomy should have been completed. Open, minimal invasive or hybrid surgical approaches are acceptable as long as the requirements above are fulfilled.
Regardless of the type of surgery a minimum of 15 lymph nodes should have been resected and examined.
Recovered from surgery and fit for study treatment as assessed by a multidisciplinary team. Surgery should have been completed 2 to 3 months before randomization.
ypN1-3 status according to current (8th) version of TNM classification system. In case of an ypN0 status patients must meet the inclusion criterion of R1 resection.
R0 or R1 resection according to current (8th) version of TNM classification system. In case of R0 resection, patients must meet the inclusion criterion of ypN1-3
WHO performance status score of 0 or 1
Age ≥ 18 years
Adequate organ function assessed within 7 days before randomization:
White blood cell count (WBC) > 2 x 109/L
Absolute neutrophil count (ANC) > 1.5 x 109/L
Platelets ≥ 100 x 109/L
Hemoglobin ≥ 9 g/dL
Measured/calculated creatinine clearance ≥ 60 mL/min (according to Cockroft-Gault formula).
Total bilirubin within normal limits (if the patient has documented Gilbert's disease ≤ 1.5 * ULN or direct bilirubin ≤ ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5ULN
Cardiac assessment by 12 Lead ECG and if clinically indicated, cardiac function assessment (using either echocardiography or MUGA scan)
All toxicities (exception alopecia) attributed to prior anti-cancer therapy must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug.
Women of childbearing potential (WOCBP*) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within 24 hours prior to randomization
Men who are sexually active with an WOCBP must adhere to contraception (condom) during the study and for a period of 7 months after the last dose of the study treatment in the experimental arm and 6 months in the control arm.
Patients of childbearing / reproductive potential should use highly effective method of birth control measures during the study treatment period and for at least 5 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion Criteria:
R2 resection status
M1 stage according to current (8th) version of TNM classification system
Patients who have undergone complete resection of metastases
Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for postoperative chemotherapy or immunotherapy
Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina pectoris, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious cardiac arrhythmia requiring medication
Subjects with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry. Adequately treated cervical carcinoma in situ, and localized non-melanoma skin cancer are no exclusion criteria, regardless of timepoint of diagnosis.
Subjects with active, known, or suspected infectious or autoimmune disease
Patients who have received antibiotics within the last 14 days before randomization are excluded.
Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll
Subjects with a condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration
Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
Subjects with > Grade 1 peripheral neuropathy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Prior or concomitant treatment with radiotherapy/radiochemotherapy
Any positive test result for HBV or HCV indicating acute or chronic infection
Known history of HIV or known AIDS and, if required by local practice or positive HIV testing at screening
Known uncontrollable hypersensitivity to the components of cisplatin/oxaliplatin, fluorouracil (5-FU) or capecitabine, epirubicine or docetaxel
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Ongoing or concomitant use of the antiviral drug sorivudine or its chemically related analogs, such as brivudine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Lordick
Organizational Affiliation
Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden, Leipzig, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maren Knoedler
Organizational Affiliation
Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden, Leipzig, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elizabeth Smyth
Organizational Affiliation
Cambridge University Hospital NHS - Cambridge, UK
Official's Role
Study Chair
Facility Information:
Facility Name
Masaryk Memorial Cancer Institute
City
Brno
Country
Czechia
Facility Name
University Hospital Hradec Kralove
City
Hradec Králové
Country
Czechia
Facility Name
CHRU de Lille - Hopital Huriez
City
Lille
Country
France
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
Country
France
Facility Name
Gustave Roussy
City
Villejuif
Country
France
Facility Name
Charite - Universitaetsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Kliniken Essen-Mitte
City
Essen
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
City
Hamburg
Country
Germany
Facility Name
SLK-Kliniken Heilbronn
City
Heilbronn
Country
Germany
Facility Name
Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden
City
Leipzig
Country
Germany
Facility Name
Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar
City
München
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen-Uni Kliniken Berg
City
Tuebingen
Country
Germany
Facility Name
Rambam Health Care Campus, Oncology Institute
City
Haifa
Country
Israel
Facility Name
Rabbin Medical Centre - Tel Aviv
City
Tel Aviv
Country
Israel
Facility Name
Azienda Ospedaliera a Papa Giovanni XXIII
City
Bergamo
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milan
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
City
Napoli
Country
Italy
Facility Name
Oslo University Hospital - Ullevaal Hospital
City
Oslo
Country
Norway
Facility Name
Maria Sklodowska-Curie Memorial Cancer Centre
City
Warsaw
ZIP/Postal Code
02 781
Country
Poland
Facility Name
Institut Catalan d'Oncologia - ICO Badalona
City
Badalona
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Complejo Hospitalario A
City
Pamplona
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
Cambridge University Hospital NHS
City
Cambridge
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32083013
Citation
Smyth E, Knodler M, Giraut A, Mauer M, Nilsson M, Van Grieken N, Wagner AD, Moehler M, Lordick F. VESTIGE: Adjuvant Immunotherapy in Patients With Resected Esophageal, Gastroesophageal Junction and Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): An Open Label Randomized Controlled Phase-2-Study. Front Oncol. 2020 Jan 30;9:1320. doi: 10.3389/fonc.2019.01320. eCollection 2019.
Results Reference
derived
Learn more about this trial
Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence
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