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Clinical Phase II Clinical Study Evaluating the Toxicity and Efficacy of mFOLFIRINOX Associated With SBRT (Stereotactic Radiotherapy) in Patients With Unresectable Locally Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03891472
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Katarzyna Kuśnierz, Medical University of Silesia

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE March 27, 2019
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2019)
  • Improvement of the therapeutic index. [ Time Frame: 24 months. ]
    Improvement of the therapeutic index by reducing the toxicity of treatment and increasing local control of the cancer process while evaluating the possibility of conversion to the surgical status.
  • Improvement of the overall survival. [ Time Frame: 60 months. ]
    Improvement of the overall survival by new treatment method.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Phase II Clinical Study Evaluating the Toxicity and Efficacy of mFOLFIRINOX Associated With SBRT (Stereotactic Radiotherapy) in Patients With Unresectable Locally Advanced Pancreatic Cancer
Official Title  ICMJE Clinical Phase II Clinical Study Evaluating the Toxicity and Efficacy of mFOLFIRINOX Associated With SBRT (Stereotactic Radiotherapy) in Patients With Unresectable Locally Advanced Pancreatic Cancer
Brief Summary

Primary goal:

Improvement of the therapeutic index by reducing the toxicity of treatment and increasing local control of the cancer process while evaluating the possibility of conversion to the surgical status.

Secondary targets:

  • Survival rate (OS) assessment in patients treated with mFOLFIRINOX + SBRT
  • Assessment of quality of life using questionnaires: EQ-5D, EORTC (QLQ-C30) and pancreatic cancer-specific QLQ PAS module 26
  • Early toxicity <3 months after completion of SBRT treatment.
  • Percentage of local control (1-year)
Detailed Description

STUDY PLAN Patients will receive initial mFOLFIRINOX (6 cycles) chemotherapy, followed by evaluation of the response to the treatment (imaging and laboratory testing) followed by SBRT, followed by mFOLFIRINOX chemotherapy.

In case of exclusion of disease progression after 10 weeks +/- 2 weeks after completion of SBRT, patients will be qualified to surgical treatment to attempt a radical surgical treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer of Pancreas
  • Unresectable Pancreatic Cancer
  • Chemotherapy Effect
  • SBRT
Intervention  ICMJE Drug: Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.
mFOLFIRINOX > SBRT > mFOLFIRINOX > Surgical Intervention
Other Names:
  • mFOLFIRINOX (Oxaliplatin, Irinotecan, Fluorouracil)
  • SBRT (Stereotactic Body Radiation Therapy)
  • Surgical Intervention (Pancreatectomy)
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signing informed consent for treatment.
  2. Age> = 18 years.
  3. Patients with histopathological diagnosis of adenocarcinoma of the pancreas.
  4. Advanced disease referred to as locally advanced definitive non-resetable, non-metastatic pancreatic cancer.
  5. No prior systemic treatment due to pancreatic adenocarcinoma
  6. No prior radiotherapy in the abdominal area
  7. No prior radical surgical treatment due to pancreatic adenocarcinoma (palliative surgical procedures such as bypass surgery or biliary tract surgery are acceptable).
  8. ECOG 0 or 1.
  9. Expected survival time in excess of 12 weeks.
  10. Adequate organ performance based on laboratory blood tests.

Exclusion Criteria:

  1. Patients diagnosed with other types of pancreatic cancer than adenocarcinomas (eg neuroendocrine cancer).
  2. Advanced disease that allows primary surgical treatment.
  3. Borderline pancreatic cancer (BRPC) disease.
  4. The presence of metastases.
  5. Previous systemic treatment because of pancreatic adenocarcinoma.
  6. Preoperative radiotherapy in the abdominal area.
  7. Previous radical surgery for pancreatic adenocarcinoma.
  8. Large surgical procedure with the exception of diagnostic biopsies within the last 4 weeks after the start of treatment and / or patients who have not fully recovered after surgery.
  9. Heart failure (NYHA Class II, III or IV)
  10. Hemodynamic instability in the course of coronary and / or valvular heart disease and / or hypertension and / or other clinical conditions (eg uncontrolled diabetes mellitus).
  11. Clinically relevant cardiac arrhythmias requiring treatment.
  12. Stroke and / or myocardial infarction history within 6 months of inclusion.
  13. Respiratory failure associated with other co-morbidities.
  14. Serious psychiatric illnesses, which, in the researcher's opinion, could have a significant negative impact on the safety of the treatment.
  15. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
  16. Transplanted organ transplant including allogeneic bone marrow transplant.
  17. Positive diagnosis for HBV or HCV indicating acute or chronic infection (for screening).
  18. HIV infection.
  19. The period of pregnancy and breastfeeding.
  20. Alcoholism or drug abuse.
  21. Limited legal capacity.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03891472
Other Study ID Numbers  ICMJE KNW/0022/KB1/71/I/16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Katarzyna Kuśnierz, Medical University of Silesia
Study Sponsor  ICMJE Medical University of Silesia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Silesia
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP