Clinical trial NCT03158779: Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer
Official title: Phase II Trial Evaluating Stereotactic Body Radiation Therapy (SBRT) After Induction Chemotherapy for Patients With Locally Advanced Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of acute toxicities
timeFrame: 2 years
measure: Incidence of late toxicities
timeFrame: 4 years
measure: Freedom from local progression in treated patients
timeFrame: 2 years
measure: Progression free-survival of treated patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Marta Scorsetti, MD
role: PRINCIPAL_INVESTIGATOR
References: