Pancreatic Cancer, Stereotactic Body Radiotherapy
Conditions
Keywords
pancreatic cancer, stereotactic body radiotherapy, resectability
Brief summary
Evaluation of clinical response in terms of resectability of patients with locally advanced pancreatic cancer treated with neoadjuvant chemotherapy plus stereotactic body radiotherapy.
Detailed description
Aim of the study is to define the percentage of patients with down-staging and clinical response after having undergone stereotactic radiotherapy + chemotherapy with neoadjuvant intent for locally advanced pancreatic carcinoma or borderline resectable at the time of diagnosis. The study evaluates the response to therapy in terms of resectability, of acute and delayed treatment-related toxicity, of overall survival and progression-free survival and also assesses patient's quality of life.
Interventions
RADIATIONSBRT plus chemotherapy
Neoadjuvant stereotactic body radiotherapy (SBRT, 30 Gy in 5 fractions) plus chemotherapy with Folfirinox
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histological diagnosis of locally advanced pancreatic carcinoma, not upfront surgically treated (according to NCCN resectability criteria), without distant metastases * NCCN criteria resectability status * patient's age, performance status, possible presence of comorbidity should also be considered to decide the optimal approach (upfront surgery versus neoadjuvant treatment). * If the chemotherapy treatment induces the disease to a condition of resectability, the patient will undergo a surgical evaluation * indication for radiotherapy treatment * ECOG 0-2 * obtaining informed consent * not pregnant or breastfeeding
Exclusion criteria
* ECOG\> 2 * presence of internal diseases for which radiotherapy is contraindicated, or diseases of the connective system, or gastric or duodenal ulcer in progress or acute diverticulitis, ulcerative colitis * comorbidity which in the opinion of the referring physician may constitute a risk for participation in the study * lack of availability for clinical-instrumental follow-up * previous abdominal radiotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response to the treatment in terms of resectability | 24 months | Percentage of patients with pancreatic cancer judged to be inoperable who have undergone surgical treatment after neoadjuvant chemotherapy plus stereotactic body radiotherapy. Response is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria) by a multidisciplinary team of surgeons, radiologist, oncologist, radiation oncologist according to resectability criteria NCCN v. 2017. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 24 months | Months of survival since the diagnosis |
| Progression free survival | 24 months | Progression-free survival (PFS) after radiotherapy is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria). Also laboratory tests are performed (CA 19.9) |
| Toxicity | 24 months | Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03 |
| Quality of life | 24 months | QoL are assessed with Cancer Linear Analog Scale (CLAS) which evaluating well-being, fatigue, and ability to perform daily activities (values range from 0 that represents the best status to 10 that represents the worst one) |
Countries
Italy
Contacts
Primary ContactAlessio G Morganti, MD
Outcome results
None listed