Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Phase II Trial Evaluating Stereotactic Body Radiation Therapy (SBRT) After Induction Chemotherapy for Patients With Locally Advanced Unresectable Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158779
• Other study ID #: 1736
• Status: Completed
• Phase: Phase 2
• Start date: May 10, 2017
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Freedom from local progression in treated patients	Evaluation of proportion of patients free from local progression according to RECIST criteria	2 years
Secondary	Progression free-survival of treated patients	Evaluation of proportions of patients alive and free form progression according to RECIST criteria	2 years