Trial Title:
Surveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial
NCT ID:
NCT06115629
Condition:
Esophageal Cancer
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Surveillance
Cancer recurrence
Quality of life
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Surveillance protocol
Description:
Imaging surveillance will entail a computed tomography scan of the chest, abdomen and
pelvis, as well as clinical review, every 6 months for 36 months post surgery along with
an endoscopy at 12 months post surgery.
Arm group label:
Imaging surveillance
Summary:
Cancer of the food pipe (oesophagus) and stomach are increasingly common. Currently, most
patients with cancer of the oesophagus and stomach are treated with surgery with or
without additional chemotherapy or radiotherapy. In recent years there have been
improvements in survival from these two cancers, due to better therapies, less invasive
surgery and earlier detection. Despite these improvements, in around half of patients
treated with surgery, the cancer will return, usually within the first three years.
At present there is very little evidence as to how patients who have been treated for
cancer of the oesophagus or stomach should be followed up after surgery and whether
different methods of follow-up could improve survival. Currently, national and
international guidelines do not provide consistency in their recommendations for
follow-up after surgery.
The SARONG-II study will investigate if regular radiological scans can lead to earlier
detection of a cancer returning, at a stage when it may be more readily treatable. This
means that participants who agree to take part will be allocated by chance to either more
intensive imaging surveillance (including regular radiological scans and a camera test
(endoscopy)) or clinical follow-up.
The study aims to recruit at least 952 participants in Europe over a 32-month period.
Patients undergoing surgery for oesophageal or stomach cancer will be invited to
participate in the study at around 4 to 8 weeks after their surgery.
(i) The imaging surveillance group will receive a review in clinic or by telephone with a
member of the surgical team, and a radiological scan at 6, 12, 18, 24, 30 and 36 months
after randomisation. They will also receive endoscopy at 12 months after randomisation
(ii) The clinical surveillance group will receive a review in clinic or by telephone at
6, 12, 18, 24, 30 and 36 months. After this they will be either discharged to their local
doctor or receive a review in clinic with a member of the surgical team every year
according to local practice
The main aim of this study will be to determine whether earlier detection of cancer
through more intensive follow-up results in improved survival and better quality of life
for patients with oesophagus or stomach cancer. The investigators anticipate the results
of the study may have significant practice-changing impact for patients undergoing
follow-up after surgery for oesophagus and stomach cancer.
Detailed description:
It is an encouraging trend that the overall survival rate for oesophagogastric cancer has
doubled over the last 20 years. For patients with locally advanced disease treated with
curative intent, 5 year survival in the modern era approaches 50%. Relevant factors
include earlier diagnosis, improvements in staging, and quality improvements in the
standard modalities of surgery, chemotherapy and radiation therapy, increasingly
delivered in high volume centers. When local or systemic failure occurs, where
therapeutic nihilism may have once prevailed, a menu of therapeutic options can now be
considered, such as immunotherapy, salvage locoregional surgery, resection of
oligometastatic disease, brachytherapy, radiofrequency ablation (RFA) and stereotactic
radiation therapy.
In the context of this changing landscape and expanded armamentarium, a key question, as
yet unresolved, is how patients treated with curative intent should be optimally
followed-up. The options include an intensive imaging surveillance approach using
clinical assessment, cross-sectional imaging, and endoscopy, or one purely based on
symptomatic follow-up to trigger further investigation.
The debate for oesophagogastric cancer is limited by a paucity of evidence. This may
reflect both a lack of attention to this topic in research, with no RCTs, and relatively
poor quality cohort and observational studies with considerable heterogeneity. The
approach to surveillance varies considerably internationally. In Japan, a nationwide
survey reported that that high intensity surveillance was common, with endoscopic
surveillance utilized in over 80% of patients, in contrast to approximately 6% in
Australia and New Zealand. In Europe, the European Registration of Cancer Care (EURECCA)
Upper Gastrointestinal group reported a brief summary from 10 Centers, and highlighted
substantial differences in elements of surveillance, in particular of cross-sectional
imaging, which was sought in just 40% of patients. Guidelines also vary, for instance the
European Society for Medical Oncology guidelines currently state, "With the exception of
endoscopic or operative salvage after initial non-operative management, there is no
evidence that regular follow-up has an impact on survival outcomes", while the UK NICE
guidelines state, "for people without symptoms or evidence of residual disease after
treatment for oesophagogastric cancer with curative intent, do not offer routine clinical
follow-up or radiological surveillance solely for the detection of recurrent disease".
It is clear that research is urgently required on this important topic that will inform
everyday practice and future guidelines. In this context, a European collaborative
multicenter study was established with the primary objective of assessing the current
situation in specialist centers internationally and its impact on survival and quality of
life.
In this study, the investigators first surveyed 27 European centres, and identified
marked variation in surveillance practices, with only 37% of centres providing routine
radiologic surveillance for detection of recurrence, and only 19% undertaking routine
surveillance endoscopy. The investigators then undertook a European multicentre cohort
study, which included 4682 patients. At median follow-up 60 months, 47.5% developed
recurrence, oligometastatic in 39%. Intensive surveillance, defined as a computed
tomography scan undertaken at least annually for three years after surgery, was
associated with reduced symptomatic recurrence and increased tumor-directed therapy. On
multivariable analysis, no overall survival benefit was observed among all patients
(HR1.01 [0.89-1.13]), but overall survival was improved following intensive surveillance
for those who underwent surgery alone and those with lower pathological (y)pT stages.
Intensive surveillance was associated with similar overall HRQL. This study established
that there is widespread heterogeneity in surveillance protocols in Europe, and the vast
majority of centres agreed there is a need for an RCT examining this issue.
The SARONG-II study is an international multicentre, open-label, two-arm, parallel
design, superiority randomised controlled trial. 952 patients (476 in each of two trial
arms) will be recruited from approximately 14 sites in Europe. Participants will be
randomised to either imaging surveillance every 6 months for 36 months and an endoscopy
at 12 months postrandomisation or clinical follow-up for 36 months.
Primary Outcome Measure:
All-cause mortality defined as death from any cause. Participants who have not been
observed to die during the course of the study will have their survival time censored at
their last known follow-up date.
Secondary Outcome Measures:
1. a) Disease-specific mortality, defined as known oesophageal or gastric cancer
recurrence at the time of death.
b) Pattern of tumour recurrence, defined as the incidence of loco-regional or
distant recurrence.
c) Treatment of tumour recurrence, ie. the requirement for chemotherapy, surgery,
immunotherapy, radiotherapy, chemoradiotherapy, best supportive care or other as
determined by the clinical team at the treating site.
d) Rates of oligometastatic (one site) tumour recurrence. e) Rates of
multi-metastatic (several sites) tumour recurrence.
2. HRQoL, including anxiety or depression and worry of cancer returning as measured by
the following validated questionnaires: EQ- 5D-5L, EORTC QLQ-C30 and QLQ-OG25 and
Cancer Worry Scale (CWS).
3. Incremental cost per quality adjusted life year (QALY)
Criteria for eligibility:
Criteria:
A patient will be eligible for inclusion in this study if all of the following criteria
apply:
1. Has undergone surgical resection for curatively intended treatment of oesophageal or
gastric cancer (adenocarcinoma and squamous cell carcinoma) with or without
neoadjuvant/adjuvant chemotherapy or radiotherapy or immunotherapy (or in
combination).
2. Aged 18 years or over
3. Willing and able to give informed consent
A patient with not be eligible for the trial if any of the following apply:
1. Other cancer(s) undergoing treatment or surveillance
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Cologne
Address:
City:
Cologne
Country:
Germany
Contact:
Last name:
Wolfgang Schröder
Investigator:
Last name:
Thomas Zander
Email:
Sub-Investigator
Facility:
Name:
Mercy University Hospital
Address:
City:
Cork
Country:
Ireland
Contact:
Last name:
Evelyn Flanagan, BSc MSc PhD MBA
Investigator:
Last name:
Thomas Murphy
Email:
Principal Investigator
Facility:
Name:
Trinity St. James's Cancer Institute
Address:
City:
Dublin
Country:
Ireland
Contact:
Last name:
Claire L Donohoe, PhD FRCS MEd
Investigator:
Last name:
John V Reynolds, MD FRCS
Email:
Sub-Investigator
Facility:
Name:
Galway University Hospital
Address:
City:
Galway
Country:
Ireland
Contact:
Last name:
Paul Carroll
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli
Address:
City:
Roma
Country:
Italy
Contact:
Last name:
Cristina Vacca
Investigator:
Last name:
Laura Lorenzon
Email:
Principal Investigator
Facility:
Name:
Oslo University Hospital
Address:
City:
Oslo
Country:
Norway
Contact:
Last name:
Tom Mala
Facility:
Name:
University Hospital of Northern Norway
Address:
City:
Tromsø
Country:
Norway
Contact:
Last name:
Eirik Kjus Aahlin
Facility:
Name:
St. Olav University Hospital
Address:
City:
Trondheim
Country:
Norway
Contact:
Last name:
Lars Cato Rekstad
Facility:
Name:
Linköping University Hospital
Address:
City:
Linköping
Country:
Sweden
Contact:
Last name:
David Edholm
Facility:
Name:
Skåne University Hospital
Address:
City:
Lund
Country:
Sweden
Contact:
Last name:
Jan Johansson
Facility:
Name:
Karolinska Institutet
Address:
City:
Stockholm
Country:
Sweden
Contact:
Last name:
Maria Lampi
Investigator:
Last name:
Magnus Nilsson
Email:
Sub-Investigator
Facility:
Name:
Uppsala University Hospital
Address:
City:
Uppsala
Country:
Sweden
Contact:
Last name:
Jakob Hedberg
Facility:
Name:
Örebro University Hospital
Address:
City:
Örebro
Country:
Sweden
Contact:
Last name:
Eva Szabo
Start date:
November 2023
Completion date:
November 2029
Lead sponsor:
Agency:
University of Dublin, Trinity College
Agency class:
Other
Collaborator:
Agency:
Trinity St. James's Cancer Institute
Agency class:
Other
Collaborator:
Agency:
University of Oxford
Agency class:
Other
Collaborator:
Agency:
Karolinska Institutet
Agency class:
Other
Source:
University of Dublin, Trinity College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06115629
