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

NCT06946420 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 0001898 24
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Therapy; SBRT; Pancreatic Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Absence of symtomps

  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

  From the week after the treatment up to 12 months after

Secondary Outcomes (2)

• Pain level

  From the week after the treatment up to 12 months after

• Radiotherapy use

  From the week after the treatment up to 12 months after

Study Arms (2)

Standard systemic therapy (chemotherapy) without RT/SBRT

OTHER

Patients will undergo only standard systemic treatment (chemotherapy drugs at the discretion of the oncologist) without receiving radiotherapy or stereotactic treatment.

Drug: Standard systemic therapy (chemotherapy) without RT/SBRT

RT / SBRT before standard systemic therapy (chemotherapy)

EXPERIMENTAL

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))

Radiation: SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy

Interventions

SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy RADIATION

This group of patients will first undergo radiotherapy on the primary pancreatic lesion and stereotactic treatment on the metastatic sites before being started on standard systemic therapy (chemotherapy)

Also known as: SBRT, Radiation therapy, pancreatic cancer

RT / SBRT before standard systemic therapy (chemotherapy)

Standard systemic therapy (chemotherapy) without RT/SBRT DRUG

This group of patients will undergo standard systemic therapy (chemotherapy drugs chosen by oncologist) without radiotherapy treatment

Also known as: systemic therapy, No radiation, standard

Standard systemic therapy (chemotherapy) without RT/SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Universitario Agostino Gemelli IRCSS

Rome, RM, 00168, Italy

Location

MeSH Terms

Interventions

Radiosurgery; Radiotherapy; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 27, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): January 10, 2030
• Study Completion (Estimated): January 10, 2031
• Last Updated: April 27, 2025

Record last verified: 2025-03

Locations

IT (1)