Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
SBRT and chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
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.
Sites / Locations
- Humanitas Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SBRT and chemotherapy
Arm Description
Participants received 4 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered. A 3-weeks break from chemotherapy and restaging with thorax-abdominal CT scan to confirm the absence of distant metastases was required before SBRT delivery. Before SBRT simulation, patients may will have implanted fiducial into the pancreatic tumor. The SBRT schedule will be [6 x 9 Gy = 54 Gy] delivered in consecutive days.
Outcomes
Primary Outcome Measures
Overall survival
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 Outcome Measures
Incidence of acute toxicities
Evaluation of early post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Incidence of late toxicities
Evaluation of late post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Freedom from local progression in treated patients
Evaluation of proportion of patients free from local progression according to RECIST criteria
Progression free-survival of treated patients
Evaluation of proportions of patients alive and free form progression according to RECIST criteria
Full Information
NCT ID
NCT03158779
First Posted
May 4, 2017
Last Updated
September 14, 2022
Sponsor
Istituto Clinico Humanitas
1. Study Identification
Unique Protocol Identification Number
NCT03158779
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SBRT and chemotherapy
Arm Type
Experimental
Arm Description
Participants received 4 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered. A 3-weeks break from chemotherapy and restaging with thorax-abdominal CT scan to confirm the absence of distant metastases was required before SBRT delivery.
Before SBRT simulation, patients may will have implanted fiducial into the pancreatic tumor.
The SBRT schedule will be [6 x 9 Gy = 54 Gy] delivered in consecutive days.
Intervention Type
Combination Product
Intervention Name(s)
SBRT and chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Incidence of acute toxicities
Description
Evaluation of early post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Time Frame
2 years
Title
Incidence of late toxicities
Description
Evaluation of late post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Time Frame
4 years
Title
Freedom from local progression in treated patients
Description
Evaluation of proportion of patients free from local progression according to RECIST criteria
Time Frame
2 years
Title
Progression free-survival of treated patients
Description
Evaluation of proportions of patients alive and free form progression according to RECIST criteria
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Scorsetti, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humanitas Research Hospital
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer
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