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Evaluation of clinical response in terms of resectability of patients with locally advanced pancreatic cancer treated with neoadjuvant chemotherapy plus stereotactic body radiotherapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT plus chemotherapy | Experimental | Patients with unresectable or "borderline resectable" locally advanced pancreatic carcinoma at time of diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT plus chemotherapy | Radiation | Neoadjuvant stereotactic body radiotherapy (SBRT, 30 Gy in 5 fractions) plus chemotherapy with Folfirinox |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response to the treatment in terms of resectability | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Months of survival since the diagnosis | 24 months |
| Progression free survival | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessio G Morganti, MD | Contact | +390512143564 | rt.unibo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alessio G Morganti, MD | Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital | Recruiting | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| 24 months |
| Toxicity | Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03 | 24 months |
| Quality of life | 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) | 24 months |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |