Evaluation Of SBRT For Patients With Locally Advanced Unresectable Pancreatic Cancer

Study Overview

Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer

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.

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).

Pancreatic Cancer

COMBINATION_PRODUCT: SBRT and chemotherapy

1736

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-05-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-09-14
First Submitted that Met QC Criteria 2017-05-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-09-15
First Posted (ACTUAL) 2017-05-18	Results First Posted N/A	Last Verified 2022-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: SBRT and chemotherapy 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	COMBINATION_PRODUCT: SBRT 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: SBRT and chemotherapy

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

COMBINATION_PRODUCT: SBRT 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.

Primary Outcome Measures	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures	Measure Description	Time Frame
Incidence of acute toxicities	Evaluation of early post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.	2 years
Incidence of late toxicities	Evaluation of late post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.	4 years
Freedom from local progression in treated patients	Evaluation of proportion of patients free from local progression according to RECIST criteria	2 years
Progression free-survival of treated patients	Evaluation of proportions of patients alive and free form progression according to RECIST criteria	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Metastatic disease
Prior abdominal radiotherapy
Other malignancies diagnosed within 5 years
Gastric or duodenal obstruction.
Concurrent chemotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Marta Scorsetti, MD, Istituto Clinico Humanitas

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record