eoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer

Phase 3

Recruiting

• Conditions: carcinoma of the oesophagus; oesophageal cancer; 10017990; 10017991

• Registration Number: NL-OMON50242
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 738

Inclusion Criteria

Patients who are planned to undergo or who recently underwent neoadjuvant
chemoradiotherapy according to CROSS, followed by surgical resection for
histologically proven oesophageal squamous cell carcinoma or adenocarcinoma of
the oesophagus or oesophago-gastric junction;, Age >=18;, Written, voluntary,
informed consent.

Exclusion Criteria

Language difficulty, dementia or altered mental status prohibiting the
understanding and giving of informed consent and to complete quality of life
questionnaires;, Non-FDG-avid tumour at baseline PET-CT scan.
Previous treatment with endoscopic resection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is overall survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the percentage of patients who do not undergo<br /><br>surgery, quality of life, clinical irresectability (cT4b) rate, radical<br /><br>resection rate, postoperative complications, progression free survival, distant<br /><br>dissemination rate, and cost-effectiveness</p><br>