NCT06946420Active, not recruitingPhase 3
SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy
SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy, a Phase III Randomized Multicentric Trial
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 108 (actual)
- First submitted
- 26 Mar 2025
- Start date
- 10 Jan 2025
- Primary completion date
- 10 Jan 2030
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Pancreatic cancer
- NCT number
- NCT06946420
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 108
- From 10 Jan 2025 to the primary completion date, 10 Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Technical or organizational impracticality to the eventual termination of radiation treatments Within 25 days after randomization
- Previous radiation therapy
- Previous radiometabolic therapy
- Previous chemotherapy, immunotherapy or target therapy
Other
- Metastatic picture of line subsequent to the first
- 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
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico Universitario Agostino Gemelli IRCSS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.