Pancreatic Cancer Metastatic, Radiation Therapy, SBRT
Conditions
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.
Interventions
RADIATIONSBRT 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)
DRUGStandard systemic therapy (chemotherapy) without RT/SBRT
This group of patients will undergo standard systemic therapy (chemotherapy drugs chosen by oncologist) without radiotherapy treatment
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of symtomps | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain level | From the week after the treatment up to 12 months after | Level of metastasis-associated or primary pain (presence/absence, level and response) |
| Radiotherapy use | 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) |
Countries
Italy
Outcome results
None listed