Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer

NCT ID: NCT03158779

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2022-07-01

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).

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

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.

Group Type: EXPERIMENTAL

SBRT and chemotherapy

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Michele Tedeschi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta Scorsetti, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Humanitas Research Hospital

Rozzano, Milan, Italy

Countries

Italy

Other Identifiers

1736

Identifier Type: -

Identifier Source: org_study_id