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Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03158779
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Combination Product: SBRT and chemotherapy Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Evaluating Stereotactic Body Radiation Therapy (SBRT) After Induction Chemotherapy for Patients With Locally Advanced Unresectable Pancreatic Cancer
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 28, 2021

Resource links provided by the National Library of Medicine


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.

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.

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 :
  1. Overall survival [ Time Frame: 2 years ]
    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 :
  1. Incidence of acute toxicities [ Time Frame: 2 years ]
    Evaluation of early post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

  2. Incidence of late toxicities [ Time Frame: 4 years ]
    Evaluation of late post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

  3. Freedom from local progression in treated patients [ Time Frame: 2 years ]
    Evaluation of proportion of patients free from local progression according to RECIST criteria

  4. Progression free-survival of treated patients [ Time Frame: 2 years ]
    Evaluation of proportions of patients alive and free form progression according to RECIST criteria



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158779


Contacts
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Contact: Tiziana Comito, MD +390282247244 tiziana.comito@cancercenter.humanitas.it
Contact: Marta Scorsetti, MD +390282248524 marta.scorsetti@hunimed.eu

Locations
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Italy
Humanitas Research Hospital Recruiting
Rozzano, Milan, Italy, 20089
Contact: Marta Scorsetti, MD PhD    +390282248524    marta.scorsetti@hunimed.eu   
Contact: Tiziana Comito, MD    +390282247244    tiziana.comito@cancercenter.humanitas.it   
Principal Investigator: Marta Scorsetti, MD PhD         
Sub-Investigator: Tiziana Comito, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Marta Scorsetti, MD Istituto Clinico Humanitas

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Responsible Party: Michele Tedeschi, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03158779     History of Changes
Other Study ID Numbers: 1736
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases