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

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Active, not recruiting; Phase 3

Conditions: Radiation Therapy; Pancreatic Cancer Metastatic; SBRT

Treatments: Drug: Standard systemic therapy (chemotherapy) without RT/SBRT; Radiation: SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06946420

0001898 24

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Standard systemic therapy (chemotherapy) without RT/SBRT

Other group

Description:

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

Treatment:

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

RT / SBRT before standard systemic therapy (chemotherapy)

Experimental group

Description:

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))

Treatment:

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