Cancer of PancreasPhase 2NCT03891472
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 study testing Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy. in people with Cancer of Pancreas and Unresectable Pancreatic Cancer, run by Medical University of Silesia at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Pancreas, Unresectable Pancreatic Cancer, Chemotherapy Effect
- What is being tested?
- Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2017to 31 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.
- Keywords
- mFOLFIRINOX, SBRT, Unresectable Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.Drug
Also called mFOLFIRINOX (Oxaliplatin, Irinotecan, Fluorouracil), SBRT (Stereotactic Body Radiation Therapy), Surgical Intervention (Pancreatectomy)
mFOLFIRINOX > SBRT > mFOLFIRINOX > Surgical Intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months.
Improvement of the overall survival.
Improvement of the overall survival by new treatment method.
Measured: 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Jan 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Kuśnierz, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891472
- Sponsor's protocol ID
- KNW/0022/KB1/71/I/16
- Status last verified
- Nov 2019
- First submitted
- 11 Mar 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03891472
- Acronym / sponsor ID
- KNW/0022/KB1/71/I/16
- Keywords
- mFOLFIRINOX, SBRT, Unresectable Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.Also: mFOLFIRINOX (Oxaliplatin, Irinotecan, Fluorouracil), SBRT (Stereotactic Body Radiation Therapy), Surgical Intervention (Pancreatectomy)mFOLFIRINOX > SBRT > mFOLFIRINOX > Surgical Intervention | Drug | Arm 1 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy. in people with Cancer of Pancreas and Unresectable Pancreatic Cancer, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the therapeutic index. (time frame: 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019; AzTrials last refreshed its copy on 3 Nov 2026.