Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients with Oesophageal Cancer (VALUE)

Launched by UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST · May 28, 2024

Keywords

ClinConnect Summary

The VALUE trial is a study that aims to understand how endoscopic ultrasound (EUS) is used in patients with oesophageal cancer and how it affects their treatment plans. EUS is a special procedure that helps doctors see inside the oesophagus and nearby areas. The trial will look at whether the results from EUS lead to changes in how doctors manage the patient's disease, which could include different treatment options.

To be eligible for this trial, participants must be at least 16 years old and have been diagnosed with oesophageal cancer confirmed by a biopsy. They should be referred for an EUS exam as part of their standard care and have a type of cancer that can potentially be treated with surgery or other radical methods. Patients who have had prior treatment for their cancer or have cancer that has spread to other parts of the body are not eligible. Those who join the trial can expect to undergo an EUS as part of their routine care, and their experiences will help improve future treatments for oesophageal cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 16 or above with first diagnosis of biopsy-confirmed oesophageal cancer.
• • 2. Referred for EUS examination as part of standard of care investigations.
• • 3. Tumour location in the oesophagus, or gastro-oesophageal junction (Siewert types I-III)
• • 4. MDT decision that patient is potentially curable with radical treatment (e.g., endoscopic treatment, surgery +/- neoadjuvant therapy, or definitive chemoradiotherapy)
• • 5. Prior staging with CT and PET-CT
• • 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• • 7. Clinical staging of T1-T4, N0-N3, M0 disease
• • 8. Adenocarcinoma or squamous cell carcinoma (SCC) histopathological cell type
• Exclusion Criteria:
• • 9. Recurrent or residual disease
• • 10. Distant metastatic disease detected before EUS.
• • 11. Previous oesophagectomy or oesophageal radiotherapy
• • 12. Unable to undergo EUS examination.
• • 13. Concurrent malignancy e.g., second primary tumour
• • 14. Other histopathological cell type