Condition: Esophageal Cancer · Gastric (Stomach) Cancer · Gastric Adenocarcinoma · Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Purpose of the Study: This clinical study investigates whether a shorter or longer duration of systemic therapy before local treatment (surgery or radiation) results in better disease control in patients with esophageal or gastric cancer with a limited number of metastases, also known as oligometastases. Background: In about 25% of patients with advanced esophageal or gastric cancer, the disease spreads to only a few sites (oligometastatic disease). Prior studies suggest that local treatment after systemic therapy may extend survival in this subgroup. However, it is unclear how long systemic therapy should last before initiating local treatment. The OMEC-5 study aims to clarify this and identify potential biomarkers for treatment response. Study Design: Initiated by Amsterdam UMC and UMCU and conducted in multiple hospitals across Europe. Total of 414 patients to be enrolled. Duration: \~53 months (35 months enrollment + 18 months follow-up). Approved by the medical ethics committee at Amsterdam UMC. Procedure: Eligibility screening: Includes physical exam, blood tests (incl. circulating tumor cells), medical history review, and confirmation of oligometastases by an expert panel. Initial treatment: All participants receive 4 months of standard systemic therapy (chemotherapy + immunotherapy and/or targeted therapy depending on tumor markers like HER2 or Claudin 18.2). Response assessment (Review 1): Imaging and/or laparoscopic examination. If oligometastases persi…
This description comes directly from the study's public registry record.
Hanneke van Laarhoven, MD, PhD, PhD · +31204444321 · h.vanlaarhoven@amsterdamumc.nl
Richard van Hillgersberg, MD, PhD · r.vanhillegersberg@umcutrechht.nl
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| Amsterdam University Medical Center | Amsterdam, Netherlands | Recruiting |
| UMC Utrecht | Utrecht, Netherlands | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07000253