SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy

Phase 3

Active, not recruiting

• Conditions: Radiation Therapy; SBRT; Pancreatic Cancer Metastatic
• Interventions: Drug: Standard systemic therapy (chemotherapy) without RT/SBRT; Radiation: SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy

• Registration Number: NCT06946420
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-10
• Status Verified: 2025-03
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27
• Primary Completion: 2030-01-10
• Study Completion: 2031-01-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard systemic therapy (chemotherapy) without RT/SBRT	Standard systemic therapy (chemotherapy) without RT/SBRT	Patients will undergo only standard systemic treatment (chemotherapy drugs at the discretion of the oncologist) without receiving radiotherapy or stereotactic treatment.
RT / SBRT before standard systemic therapy (chemotherapy)	SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy	Combination of RT on primary pancreatic Gross Tumor Volume (GTV) (SBRT or RT) + SBRT on each of the distal lesions SBRT or RT will be delivered immediately before the initiation of systemic therapy ((chemotherapy drugs at the discretion of the oncologist))

Primary Outcome Measures

Name	Time	Method
Absence of symtomps	From the week after the treatment up to 12 months after	Comparison between the experimental arm and the standard arm in terms of pain reduction or absence of pain (particularly with regard to abdominal pain and widespread pain from disease) using NRS scale, one-dimensional 11-point scale that assesses pain intensity in adult

Secondary Outcome Measures

Name	Time	Method
Pain level	From the week after the treatment up to 12 months after	Level of metastasis-associated or primary pain (presence/absence, level and response)
Radiotherapy use	From the week after the treatment up to 12 months after	Rate of recourse to Radiotherapy for pain, obstruction, bleeding or other symptom referable to the primary at 6 months from randomization (and not present at randomization)

Trial Locations

Locations (1)

Policlinico Universitario Agostino Gemelli IRCSS; 🇮🇹 Rome, RM, Italy