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NCT06115629Not yet recruitingPhase 3

Surveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial

Open Label International Multicentre Randomised Controlled Trial of Intensive Surveillance vs. Standard Postoperative Follow-up in Patients Undergoing Surgical Resection for Oesophageal and Gastric Cancer

Source: ClinicalTrials.gov · Last updated 3 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
952 (estimated)
First submitted
23 Oct 2023
Start date
Nov 2023
Primary completion date
Nov 2026
Lead sponsor
University of Dublin, Trinity College
NCT number
NCT06115629

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 952
  • From Nov 2023 to the primary completion date, Nov 2026
  • 13 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • A patient will be eligible for inclusion in this study if all of the following criteria apply:
  • 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).
  • Aged 18 years or over
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Cologne
Coordinator of this site? Confirm its status
CologneGermanyUnknown status
Mercy University Hospital
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CorkIrelandUnknown status
Trinity St. James's Cancer Institute
Coordinator of this site? Confirm its status
DublinIrelandUnknown status
Galway University Hospital
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GalwayIrelandUnknown status
Fondazione Policlinico Universitario Agostino Gemelli
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Oslo University Hospital
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OsloNorwayUnknown status
University Hospital of Northern Norway
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TromsøNorwayUnknown status
St. Olav University Hospital
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TrondheimNorwayUnknown status
Linkoping University Hospital
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LinköpingSwedenUnknown status
Skåne University Hospital
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LundSwedenUnknown status
Örebro University Hospital
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ÖrebroSwedenUnknown status
Karolinska Institutet
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StockholmSwedenUnknown status
Uppsala University Hospital
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UppsalaSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.

Surveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial (NCT06115629) – Frontlight Research