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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

Primary Purpose

Cancer of Pancreas, Unresectable Pancreatic Cancer, Chemotherapy Effect

Status

Completed

Phase

Phase 2

Locations

Poland

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Cancer of Pancreas focused on measuring mFOLFIRINOX, SBRT, Unresectable Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Patients diagnosed with other types of pancreatic cancer than adenocarcinomas (eg neuroendocrine cancer).
Advanced disease that allows primary surgical treatment.
Borderline pancreatic cancer (BRPC) disease.
The presence of metastases.
Previous systemic treatment because of pancreatic adenocarcinoma.
Preoperative radiotherapy in the abdominal area.
Previous radical surgery for pancreatic adenocarcinoma.
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.
Heart failure (NYHA Class II, III or IV)
Hemodynamic instability in the course of coronary and / or valvular heart disease and / or hypertension and / or other clinical conditions (eg uncontrolled diabetes mellitus).
Clinically relevant cardiac arrhythmias requiring treatment.
Stroke and / or myocardial infarction history within 6 months of inclusion.
Respiratory failure associated with other co-morbidities.
Serious psychiatric illnesses, which, in the researcher's opinion, could have a significant negative impact on the safety of the treatment.
Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Transplanted organ transplant including allogeneic bone marrow transplant.
Positive diagnosis for HBV or HCV indicating acute or chronic infection (for screening).
HIV infection.
The period of pregnancy and breastfeeding.
Alcoholism or drug abuse.
Limited legal capacity.

Sites / Locations

UCK Katowice

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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.

Improvement of the overall survival.

Improvement of the overall survival by new treatment method.

Secondary Outcome Measures

Full Information

NCT ID

NCT03891472

First Posted

March 11, 2019

Last Updated

November 9, 2019

Sponsor

Medical University of Silesia

1. Study Identification

Unique Protocol Identification Number

NCT03891472

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

July 31, 2019 (Actual)

Study Completion Date

July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Silesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

mFOLFIRINOX, SBRT, Unresectable Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

mFOLFIRINOX (Oxaliplatin, Irinotecan, Fluorouracil), SBRT (Stereotactic Body Radiation Therapy), Surgical Intervention (Pancreatectomy)

Intervention Description

mFOLFIRINOX > SBRT > mFOLFIRINOX > Surgical Intervention

Primary Outcome Measure Information:

Title

Improvement of the therapeutic index.

Description

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.

Title

Improvement of the overall survival.

Description

Improvement of the overall survival by new treatment method.

Time Frame

60 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signing informed consent for treatment. Age> = 18 years. Patients with histopathological diagnosis of adenocarcinoma of the pancreas. Advanced disease referred to as locally advanced definitive non-resetable, non-metastatic pancreatic cancer. No prior systemic treatment due to pancreatic adenocarcinoma No prior radiotherapy in the abdominal area No prior radical surgical treatment due to pancreatic adenocarcinoma (palliative surgical procedures such as bypass surgery or biliary tract surgery are acceptable). ECOG 0 or 1. Expected survival time in excess of 12 weeks. Adequate organ performance based on laboratory blood tests. Exclusion Criteria: Patients diagnosed with other types of pancreatic cancer than adenocarcinomas (eg neuroendocrine cancer). Advanced disease that allows primary surgical treatment. Borderline pancreatic cancer (BRPC) disease. The presence of metastases. Previous systemic treatment because of pancreatic adenocarcinoma. Preoperative radiotherapy in the abdominal area. Previous radical surgery for pancreatic adenocarcinoma. 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. Heart failure (NYHA Class II, III or IV) Hemodynamic instability in the course of coronary and / or valvular heart disease and / or hypertension and / or other clinical conditions (eg uncontrolled diabetes mellitus). Clinically relevant cardiac arrhythmias requiring treatment. Stroke and / or myocardial infarction history within 6 months of inclusion. Respiratory failure associated with other co-morbidities. Serious psychiatric illnesses, which, in the researcher's opinion, could have a significant negative impact on the safety of the treatment. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment. Transplanted organ transplant including allogeneic bone marrow transplant. Positive diagnosis for HBV or HCV indicating acute or chronic infection (for screening). HIV infection. The period of pregnancy and breastfeeding. Alcoholism or drug abuse. Limited legal capacity.

Facility Information:

Facility Name

UCK Katowice

City

Katowice

State/Province

Śląskie

ZIP/Postal Code

40-514

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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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