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Timing of Comprehensive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma

RecruitingPhase 2Ages 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Ams…
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In plain words

What the trial is, and whether it could suit you

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. 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 follo

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years * Ability to provide written informed consent * Histologically confirmed esophageal, gastric or gastroesophageal junction tumor with oligometastatic (M1) disease defined according to the OMEC consensus statement: * One organ with ≤3 metastases or 1 involved extra-regional lymph node station (based on the TNM 8 classification) * ≤3 unilobar liver metastases or ≤2 bilobar liver metastases * ≤ 3 unilateral lung metastases * Unilateral adrenal gland involvement * Metastasis confined to 1 bone structure or 1 soft tissue compartment * Synchronous oligometastatic disease with a resectable primary tumor or metachronous oligometastatic disease (in the event of a locoregional recurrence this should be resectable) * Metastases should be deemed amenable by the international multidisciplinary expert team for radical local treatment * WHO performance status 0-2 * Indication for checkpoint inhibition and/or targeted therapy * PD-L1 with a CPS of 1 or higher as per local clinical practice for immunotherapy use * HER2 overexpression as per local clinical practice for trastuzumab use * Claudin 18.2 overexpression as per local clinical practice for zolbetuximab use. * Any other biomarker that allows targeted therapy in first line approved by EMA * No prior systemic therapy for metastatic disease * CT-scan ≤8 weeks prior to inclusion * Ability to undergo local treatment and start systemic treatment beyond 18 weeks of total systemic treatment. Exclusion Criteria: * Squamous cell carcinoma * Brain metastases * Peritoneal or pleural carcinomatosis * Patients with MSI dMMR * Uncontrolled immunodeficiency (e.g. AIDS) * Peripheral neuropathy \>CTCAE grade 1, precluding start of full dose oxaliplatin treatment * Both organ metastasis and extra-regional lymph node metastasis * Conditions precluding local treatment or systemic therapy for oligometastatic disease: * Serious medical comorbidities precluding local treatment (e.g., interstitial lung disease in patients with pulmonary metastasis) * Clinical or radiological evidence of spinal cord compression or epidural tumor within 2 mm of the spinal cord * Simultaneous other malignancy or previous other malignancy with a disease-free period of \<5 years, except adequately treated non-melanoma skin cancer or in-situ cancers * Uncontrolled (bacterial) infections * Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments * Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias * Continuous use of immunosuppressive agents equivalent to \>10 mg daily prednisone * Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine * Pregnancy or breast feeding * Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
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What it tests

  • Chemotherapy
  • Targeted Systemic Therapy
  • Immunotherapy
  • Surgery
  • Radiotherapy
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Where

5 sites
Amsterdam University Medical Center
Amsterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
University of Oslo
Oslo, Norway
University of North Norway
Tromsø, Norway
Instituto de Investigación Sanitaria - INCLIVA
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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