Best time for minimally invasive local treatment after first-line systemic therapy for limited (oligo) esophageal or stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with oligometastatic esophageal or gastric adenocarcinoma receive standard first-line systemic therapy including chemotherapy, targeted agents and/or immunotherapy, then are assigned to shorter versus longer systemic therapy duration before minimally invasive local treatment to primary and metastatic sites. The trial enrolls about 414 patients across multiple European centers led by Amsterdam UMC and UMC Utrecht and follows participants for disease control and related outcomes for about 18 months after enrollment completes. Local treatment options include surgery or radiotherapy when the multidisciplinary team considers radical local therapy feasible. The study also collects tissue and blood samples to search for biomarkers that predict who benefits from this timing strategy.

Why it matters

Who can join: the full rules

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

Where it's running

• Amsterdam University Medical Center
  Amsterdam, Netherlands Recruiting
• University of Oslo
  Oslo, Norway Recruiting
• University of North Norway
  Tromsø, Norway Recruiting
• Instituto de Investigación Sanitaria - INCLIVA
  Valencia, Spain Recruiting
• UMC Utrecht
  Utrecht, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Peter van Rossum, MD, PhD — Amsterdam UMC
• Study coordinator: Hanneke van Laarhoven, MD, PhD, PhD
• Email: h.vanlaarhoven@amsterdamumc.nl
• Phone: +31204444321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.