Treatment of limited Oligo Metastatic disease in Esophageal and Stomach carcinoma; TOMES trial

Phase 2

• Conditions: stomach and esophagus cancer; upperGi cancer; 10017990

• Registration Number: NL-OMON52125
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 73

Inclusion Criteria

• histologically proven cT2-4aN0-2 adenocarcinoma carcinoma of the oesophagus,
gastroesophageal junction or stomach.
• histologically proven metastases from esophageal or gastric cancer or if
histologic biopsy is not possible, radiological images are highly suspicious
for metastases
• Maximum of 3 metastases in one organ OR M1 lymph node metastasis restricted
to one region (brain metastases are allowed)
• Resectable primary tumor.
• Metastases eligible for adequate local treatment.
• good performance status (WHO performance status 0-2) (appendix I).
• ASA 1-2 (appendix II).
• written informed consent.
• age >= 18
• fit to receive palliative systemic treatment

Exclusion Criteria

• pregnancy, lactating female
• peritoneal metastases or positive cytology from abdominal washings.
• patients participating in other trials that would interfere with the
implementation of this protocol.
• Patients with N3M1 disease
• Unable or unwilling to undergo systemic palliative treatment

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>progression free survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-safety<br /><br>-quality of life<br /><br>- overall survival<br /><br>- whether ctDNA can help us better select the right patients in the future who<br /><br>will benefit from this treatment</p><br>