Clinical trial NCT06946420: SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy
Official title: SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy, a Phase III Randomized Multicentric Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Radiation Therapy
SBRT
Pancreatic Cancer Metastatic
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 radiotherapy on the primary lesion and SBRT on distal metastatic sites before receiving standard systemic therapy (chemotherapy), while the other group of patients will receive only standard systemic therapy (chemotherapy) without undergoing radiotherapy.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Absence of symtomps
timeFrame: From the week after the treatment up to 12 months after
Secondary outcomes:
measure: Pain level
timeFrame: From the week after the treatment up to 12 months after
measure: Radiotherapy use
timeFrame: From the week after the treatment up to 12 months after
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli IRCSS
state: RM
Study officials:
References: