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

November 9, 2019 updated by: Katarzyna Kuśnierz, Medical University of Silesia

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Śląskie
      • Katowice, Śląskie, Poland, 40-514
        • UCK Katowice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • SBRT (Stereotactic Body Radiation Therapy)
  • mFOLFIRINOX (Oxaliplatin, Irinotecan, Fluorouracil)
  • Surgical Intervention (Pancreatectomy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months.
Improvement of the overall survival.
Time Frame: 60 months.
Improvement of the overall survival by new treatment method.
60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 24, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 9, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNW/0022/KB1/71/I/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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