Status:
ACTIVE_NOT_RECRUITING
First Line gastroeSOphageal metastatiC canceR primAry and disTant (if Oligometastatic) lEsions-directed Radiotherapy, a Multicentric, Phase III, Randomized Controlled Trial
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Gastroesophageal Cancer (GC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to evaluate the efficacy of radiotherapy on the primary site of gastroesophageal cancer and extracranial stereotactic radiotherapy on metastases before the use of standard syst...
Eligibility Criteria
Inclusion
- Patients diagnosed with gastroesophageal cancer (i.e.: esophagus, gastroesophageal junction, stomach), for both major squamous cell (SCC) and adenocarcinomatous (ADK) histologies, metastatic, candidate for first-line standard systemic treatment; either newly diagnosed in metastatic stage or first progression to metastasis.
- Obtaining informed consent.
- Patients \>18 years of age
- ECOG 0-2
- Performance of imaging (CT with mdc, MRI with mdc, CT-PET with appropriate tracer) adequate for baseline local and systemic staging and likely to be similarly repeatable at 6 and 12 months after randomization
- Confirmation at the time of randomization, by the Radiation Therapy Center, that all potentially planned treatments can be performed for the patient (if enrolled in experimental arm) within a maximum of 25 days total before referral to the Medical Oncology Center for systemic therapy
Exclusion
- Metastatic picture of line following the first
- Technical or organizational inability to the eventual deadline for radiation treatments within 25 days of randomization
- Inability to express independent consent to treatments
- Pregnancy
- Patient in hospice or with prognosis \< 6 months
- Predicted unavailability for follow-up at 6 months
- Absence of adequate or likely non-repeatable pretreatment imaging study at 6 and 12 months
- Previous radiation therapy
- Previous radiometabolic therapy
- Inability to maintain treatment position for SBRT
- Symptomatic emergent or other presentation precluding study development as planned (e.g., epidural compression of the spinal cord or cauda equina)
- Previous chemotherapy, immunotherapy or target therapy
Key Trial Info
Start Date :
November 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2029
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06922279
Start Date
November 30 2024
End Date
November 30 2029
Last Update
May 11 2025
Active Locations (1)
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1
Policlinico Universitario Agostino Gemelli IRCSS
Rome, RM, Italy, 00168