A Phase 2 interventional study of SBRT and chemotherapy in Pancreatic Cancer, sponsored by Istituto Clinico Humanitas. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-15.
Sponsored by Istituto Clinico Humanitas · Phase 2, Interventional, and Treatment
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).
3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's enrollment of 45 is close to the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
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
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.
Time frame: 2 years
Incidence of acute toxicities
Evaluation of early post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Time frame: 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.
Time frame: 4 years
Freedom from local progression in treated patients
Evaluation of proportion of patients free from local progression according to RECIST criteria
Time frame: 2 years
Progression free-survival of treated patients
Evaluation of proportions of patients alive and free form progression according to RECIST criteria
Time frame: 2 years
Plan to share: No
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Ran from May 2017 to primary completion in Jul 2022, 61 months.
Of 297 non-industry phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's 61 months is close to that.
Counting every sponsor, half of 364 studies reached it within 57 months; a quarter within 34 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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