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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Combination Product: SBRT and chemotherapy||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- Freedom from local progression in treated patients [ Time Frame: 2 years ]Evaluation of proportion of patients free from local progression according to RECIST criteria
- Progression free-survival of treated patients [ Time Frame: 2 years ]Evaluation of proportions of patients alive and free form progression according to RECIST criteria
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158779
|Contact: Tiziana Comito, MDfirstname.lastname@example.org|
|Contact: Marta Scorsetti, MDemail@example.com|
|Humanitas Research Hospital||Recruiting|
|Rozzano, Milan, Italy, 20089|
|Contact: Marta Scorsetti, MD PhD +390282248524 firstname.lastname@example.org|
|Contact: Tiziana Comito, MD +390282247244 email@example.com|
|Principal Investigator: Marta Scorsetti, MD PhD|
|Sub-Investigator: Tiziana Comito, MD|
|Principal Investigator:||Marta Scorsetti, MD||Istituto Clinico Humanitas|