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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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)

Condition or disease Intervention/treatment Phase
Cancer of Pancreas Unresectable Pancreatic Cancer Chemotherapy Effect SBRT Drug: Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy. Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 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)




Primary Outcome Measures :
  1. 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.

  2. Improvement of the overall survival. [ Time Frame: 60 months. ]
    Improvement of the overall survival by new treatment method.



Information from the National Library of Medicine

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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:

  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.

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): NCT03891472


Locations
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Poland
UCK Katowice
Katowice, Śląskie, Poland, 40-514
Sponsors and Collaborators
Medical University of Silesia
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Responsible Party: Katarzyna Kuśnierz, Investigator, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03891472    
Other Study ID Numbers: KNW/0022/KB1/71/I/16
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katarzyna Kuśnierz, Medical University of Silesia:
mFOLFIRINOX
SBRT
Unresectable Pancreatic Cancer
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
Fluorouracil
Oxaliplatin
Irinotecan
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors