Pancreatic Cancer
Conditions
Brief summary
The aim of this phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT in patients with unresectable pancreatic cancer.
Detailed description
The aim of this prospective mono-institutional phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions in patients with locally unresectable pancreatic cancer. Primary endpoint is to evaluate overall survival (OS); the overall survival time will be calculated from the start of chemotherapy to death. Secondary end points are to evaluate acute and late toxicities, freedom from local progression (FFLP) and progression free-survival (PFS). Acute and late toxicities will be scored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Local progression will be defined according to RECIST criteria. Time to toxicity and time to local or distant progression will be defined from the start of chemotherapy. Technical success will be defined as the ability to implant at least 2 fiducials in the tumor area. Migration will be defined as a change in inter-fiducial distance. Clinical success will be defined as the ability to guide the application of SBRT by using the fiducials. Any adverse event will be recorded (acute pancreatitis, clinically relevant upper GI bleeding requiring blood transfusion, abscesses in the area of the fiducials, sepsis).
Interventions
COMBINATION_PRODUCTSBRT and chemotherapy
Patients affected by locally unresectable pancreatic cancer receive integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and a Stereotactic Body Radiation Therapy with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions.
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically and/or radiologically (CT scan and/or MRI scan and/or FDG-PET) proven unresectable locally advanced pancreatic cancer, discussed multidisciplinary by tumor board. * Eighteen years of age or older, * Minimum Karnofsky Performance Status of 70. * Lesions cannot exceed 5 cm in maximum diameter. * Absence of lymph-nodal metastases * Patients received 4-6 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered. * Baseline total body CT scan performed no more than 2 months before treatment. * Placing fiducial markers through endoscopes is permitted (EUS-guided fiducials placement before the treatment). * Acceptable organ and bone marrow function. * Ability to maintain the set-up position during RT. * All patients give informed consent and sign a study-specific informed consent form.
Exclusion criteria
* Metastatic disease * Prior abdominal radiotherapy * Other malignancies diagnosed within 5 years * Gastric or duodenal obstruction. * Concurrent chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | Evaluation of SBRT after induction CT with FOLFIRINOX or Gemcitabine-Abraxane in terms of overall survival time that will be calculated from the start of chemotherapy to death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from local progression in treated patients | 2 years | Evaluation of proportion of patients free from local progression according to RECIST criteria |
| Incidence of acute toxicities | 2 years | Evaluation of early post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. |
| Incidence of late toxicities | 4 years | Evaluation of late post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. |
| Progression free-survival of treated patients | 2 years | Evaluation of proportions of patients alive and free form progression according to RECIST criteria |
Countries
Italy
Outcome results
None listed