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NCT Number: NCT06946420

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Radiation Therapy Pancreatic Cancer Metastatic SBRT

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Policlinico Universitario Agostino Gemelli IRCSS

Rome, RM, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: SBRT, Radiation therapy, pancreatic cancer

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

Other names: systemic therapy, No radiation, standard

Primary outcomes

  1. Absence of symtomps

    Time frame: 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 outcomes

  1. Pain level

    Time frame: From the week after the treatment up to 12 months after

    Level of metastasis-associated or primary pain (presence/absence, level and response)

  2. Radiotherapy use

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy, a Phase III Randomized Multicentric Trial

Acronym: SENECA

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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