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

NCT06115629 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: R&I 8335
• Study Type: interventional
• Target: 952
• Locations: 5 countries
• Sites: 13

Brief 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

Keywords

Surveillance; Cancer recurrence; Quality of life

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  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.

  36 months post randomisation

Secondary Outcomes (8)

• Disease-specific mortality

  36 months post randomisation

• Pattern of recurrence

  36 months post randomisation

• Treatment of recurrence

  36 months post randomisation

• Oligometastatic recurrence as determined using the OligoMetastatic Esophagogastric Cancer (OMEC) classification system

  36 months post randomisation

• Multimetastatic recurrence

  36 months post randomisation

Study Arms (2)

Imaging surveillance

EXPERIMENTAL

Computed tomography scan every 6 months for 3 years postoperatively. Upper gastrointestinal endoscopy at 12 months postoperatively.

Other: Surveillance protocol

Clinical surveillance

NO INTERVENTION

Clinical review every 6 months for 3 years postoperatively with further investigation according to symptoms.

Interventions

Surveillance protocol OTHER

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.

Imaging surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Trinity St. James's Cancer Institute: collaborator
• University of Oxford: collaborator
• Karolinska Institutet: collaborator

Study Sites (13)

University Hospital Cologne

Cologne, Germany

Location

Mercy University Hospital

Cork, Ireland

Location

Trinity St. James's Cancer Institute

Dublin, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Location

Oslo University Hospital

Oslo, Norway

Location

University Hospital of Northern Norway

Tromsø, Norway

Location

St. Olav University Hospital

Trondheim, Norway

Location

Linköping University Hospital

Linköping, Sweden

Location

Skåne University Hospital

Lund, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Karolinska Institutet

Stockholm, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (5)

• Elliott JA, Klevebro F, Mantziari S, Markar SR, Goense L, Johar A, Lagergren P, Zaninotto G, van Hillegersberg R, van Berge Henegouwen MI, Schafer M, Nilsson M, Hanna GB, Reynolds JV; ENSURE Study Group. Neoadjuvant Chemoradiotherapy Versus Chemotherapy for the Treatment of Locally Advanced Esophageal Adenocarcinoma in the European Multicenter ENSURE Study. Ann Surg. 2023 Nov 1;278(5):692-700. doi: 10.1097/SLA.0000000000006018. Epub 2023 Jul 20.

  PMID: 37470379 BACKGROUND

• Gujjuri RR, Clarke JM, Elliott JA, Rahman SA, Reynolds JV, Hanna GB, Markar SR; ENSURE Group Study. Predicting long-term survival and time-to-recurrence after esophagectomy in patients with esophageal cancer - Development and validation of a multivariate prediction model. Ann Surg. 2023 Jun;277(6):971-978. doi: 10.1097/SLA.0000000000005538. Epub 2022 Jul 15. No abstract available.

  PMID: 37193219 BACKGROUND

• Elliott JA, Markar SR, Klevebro F, Johar A, Goense L, Lagergren P, Zaninotto G, van Hillegersberg R, van Berge Henegouwen MI, Nilsson M, Hanna GB, Reynolds JV; ENSURE Study Group. An International Multicenter Study Exploring Whether Surveillance After Esophageal Cancer Surgery Impacts Oncological and Quality of Life Outcomes (ENSURE). Ann Surg. 2023 May 1;277(5):e1035-e1044. doi: 10.1097/SLA.0000000000005378. Epub 2022 Jan 27.

  PMID: 35129466 BACKGROUND

• Chidambaram S, Sounderajah V, Maynard N, Underwood T, Markar SR. Evaluation of postoperative surveillance strategies for esophago-gastric cancers in the UK and Ireland. Dis Esophagus. 2022 Feb 11;35(2):doab057. doi: 10.1093/dote/doab057.

  PMID: 34426840 BACKGROUND

• Chidambaram S, Sounderajah V, Maynard N, Markar SR. Evaluation of post-operative surveillance strategies for esophageal and gastric cancers: a systematic review and meta-analysis. Dis Esophagus. 2022 Dec 14;35(12):doac034. doi: 10.1093/dote/doac034.

  PMID: 35788834 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jessie A Elliott, PhD FRCS

  Trinity St. James's Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessie A Elliott, PhD FRCS

CONTACT

+353 1 410 3900; SARONG@tcd.ie

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 3, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2029
• Last Updated: November 3, 2023

Record last verified: 2023-10

Locations

IT (1); NO (3); DE (1); IE (3); SE (5)