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

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.

Conditions

• Esophageal Cancer
• Gastric Cancer

Interventions

OTHER

Surveillance protocol

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.

Sponsors & Collaborators

• Trinity St. James's Cancer Institute

  collaborator UNKNOWN

• University of Oxford

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• University of Dublin, Trinity College

  lead OTHER

Principal Investigators

• Jessie A Elliott, PhD FRCS · Trinity St. James's Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-30

Primary Completion

2026-11-30

Completion

2029-11-30

Countries

• Germany
• Ireland
• Italy
• Norway
• Sweden

Study Locations