Status:
ACTIVE_NOT_RECRUITING
SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Radiation Therapy
SBRT
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Thisi is an Interventional drug-free randomized 1:1 open-label, multicenter, phase 3 trial in patients with first-line metastatic pancreatic cancer. The interventional group of patients will undergo r...
Eligibility Criteria
Inclusion
- Patients diagnosed with pancreatic cancer, metastatic, candidate for first-line treatment standard systemic; 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 Radiotherapy Center, that it is possible to perform all treatments potentially planned for the patient (if enrolled in experimental arm) within a maximum of 25 total days prior to referral to the Medical Oncology Center for systemic therapy
Exclusion
- Metastatic picture of line subsequent to the first
- Technical or organizational impracticality to the eventual termination of radiation treatments Within 25 days after 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 :
January 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2031
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06946420
Start Date
January 10 2025
End Date
January 10 2031
Last Update
April 27 2025
Active Locations (1)
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1
Policlinico Universitario Agostino Gemelli IRCSS
Rome, RM, Italy, 00168