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CompletedNCT03891472Updated Nov 13, 2019

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

A Phase 2 interventional study of Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy. in Cancer of Pancreas, Unresectable Pancreatic Cancer and Chemotherapy Effect, sponsored by Medical University of Silesia. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-13.

Sponsored by Medical University of Silesia · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jan 2017, registered Mar 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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)
Read the 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.

02

Conditions studied

  • Cancer of Pancreas
  • Unresectable Pancreatic Cancer
  • Chemotherapy Effect
  • SBRT

Keywords

  • mFOLFIRINOX
  • SBRT
  • Unresectable Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 40 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Medical University of Silesia is the lead sponsor of 111 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.

Interventions

  • DrugPatients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.

    mFOLFIRINOX \> SBRT \> mFOLFIRINOX \> Surgical Intervention

    Also known as: mFOLFIRINOX (Oxaliplatin, Irinotecan, Fluorouracil), SBRT (Stereotactic Body Radiation Therapy), Surgical Intervention (Pancreatectomy)

06

What researchers measure

Primary outcomes

  1. Improvement of the therapeutic index.

    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.

    Time frame: 24 months.

  2. Improvement of the overall survival.

    Improvement of the overall survival by new treatment method.

    Time frame: 60 months.

07

Study locations

1 site
  • UCK Katowice
    Katowice, Śląskie 40-514, Poland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03891472
Lead sponsor
Medical University of Silesia
Responsible party
Katarzyna Kuśnierz (Investigator, Medical University of Silesia) — Principal investigator
First posted
Mar 27, 2019
Start date
Jan 1, 2017
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019
Last update
Nov 13, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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