SENECA: First Line MetaStatic PancrEatic CaNcer Primary And Distant (if Oligometastatic) LEsion DireCted RAdiotherapy

Study Overview

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

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.

N/A

Radiation Therapy
SBRT
Pancreatic Cancer Metastatic

RADIATION: SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy
DRUG: Standard systemic therapy (chemotherapy) without RT/SBRT

0001898 24

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-03-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-23
First Submitted that Met QC Criteria 2025-04-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-27
First Posted (ACTUAL) 2025-04-27	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: 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.	DRUG: Standard systemic therapy (chemotherapy) without RT/SBRT This group of patients will undergo standard systemic therapy (chemotherapy drugs chosen by oncologist) without radiotherapy treatment
EXPERIMENTAL: RT / SBRT before standard systemic therapy (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)	RADIATION: SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy 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)

Participant Group/Arm

Intervention/Treatment

OTHER: 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.

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

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

EXPERIMENTAL: RT / SBRT before standard systemic therapy (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)

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

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)

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Pain level	Level of metastasis-associated or primary pain (presence/absence, level and response)	From the week after the treatment up to 12 months after
Radiotherapy use	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)	From the week after the treatment up to 12 months after

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record