Radiation TherapyPhase 3SENECANCT06946420
SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy
A Phase 3 study testing SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy and Standard systemic therapy (chemotherapy) without RT/SBRT in people with Radiation Therapy and SBRT, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Therapy, SBRT, Pancreatic Cancer Metastatic
- What is being tested?
- SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy and Standard systemic therapy (chemotherapy) without RT/SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2025to 10 Jan 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy, a Phase III Randomized Multicentric Trial
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
- Being tested
- SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy, Standard systemic therapy (chemotherapy) without RT/SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapyRadiation
Also called SBRT, Radiation therapy, pancreatic cancer
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)
Standard systemic therapy (chemotherapy) without RT/SBRTDrug
Also called systemic therapy, No radiation, standard
This group of patients will undergo standard systemic therapy (chemotherapy drugs chosen by oncologist) without radiotherapy treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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)) Receives: Radiation: SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the week after the treatment up to 12 months after
Secondary outcomes (2)
Pain level
Level of metastasis-associated or primary pain (presence/absence, level and response)
Measured: 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)
Measured: From the week after the treatment up to 12 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start10 Jan 2025
- Primary completion10 Jan 2030 (estimated)
- Study completion10 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manfrida Stefania, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946420
- Sponsor's protocol ID
- 0001898 24
- Acronym
- SENECA
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy, a Phase III Randomized Multicentric Trial
- ClinicalTrials.gov ID
- NCT06946420
- Acronym / sponsor ID
- SENECA / 0001898 24
- Conditions
- Radiation Therapy, SBRT, Pancreatic Cancer Metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Jan 2030 (estimated)
- Study completion
- 10 Jan 2031 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard systemic therapy (chemotherapy) without RT/SBRT | Other | Drug: Standard systemic therapy (chemotherapy) without RT/SBRTPatients 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) | Experimental | Radiation: SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapyCombination 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)) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapyAlso: SBRT, Radiation therapy, pancreatic cancerThis 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) | Radiation | RT / SBRT before standard systemic therapy (chemotherapy) |
| Standard systemic therapy (chemotherapy) without RT/SBRTAlso: systemic therapy, No radiation, standardThis group of patients will undergo standard systemic therapy (chemotherapy drugs chosen by oncologist) without radiotherapy treatment | Drug | Standard systemic therapy (chemotherapy) without RT/SBRT |
Primary outcome
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
2 secondary outcomes
Pain level
Time frame: From the week after the treatment up to 12 months after
Radiotherapy use
Time frame: From the week after the treatment up to 12 months after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Radiation Therapy
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
RecruitingObservational study
A Study of Neurocognitive Tests and Questionnaires for People With Head and Neck Cancer Who Are Undergoing Radiation Therapy
Head and Neck Cancer
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy and Standard systemic therapy (chemotherapy) without RT/SBRT in people with Radiation Therapy and SBRT, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of symtomps (time frame: From the week after the treatment up to 12 months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.