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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52125
Enrollment
73
Registered
2022-07-21
Start date
2022-03-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stomach and esophagus cancer upperGi cancer

Interventions

None listed

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
progression free survival

Secondary

MeasureTime frame
-safety -quality of life - overall survival - whether ctDNA can help us better select the right patients in the future who will benefit from this treatment

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)