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Patients With Borderline Resectable Pancreatic CancerPhase 1FIRINOXNCT02148549

Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study

A Phase 1 study testing FIRINOX in people with Patients With Borderline Resectable Pancreatic Cancer, run by Wakayama Medical University at 9 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . Read more about this study

Who is it for?
Ages 20 to 74 years
What is being tested?
FIRINOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
9 sitesJapan
Study dates
Apr 2014to Feb 2017
Phase
Phase 1
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 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically proven invasive pancreatic ductal carcinoma
  • Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)
  • Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma
  • Patients indicated distal pancreatectomy with en bloc celiac axis resection
  • PS (ECOG) 0-1
  • ≧20 years old and < 75 years old
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  • First line treatment
  • The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin <2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL
  • Written informed consent to participate in this study

Who cannot join

  • Severe drug hypersensitivity
  • Multiple primary cancers within 5 years
  • Severe infection
  • With grade2 or more severe peripheral neuropathy
  • With intestinal paralysys, ileus
  • Interstitial pneumonia or pulmonary
Show all 15Show fewer
  • With uncontrollable pleural effusion or ascites
  • Receiving atazanavir sulfate
  • With uncontrollable diabetes
  • With uncontrollable heart failure, angina, hypertension, arrhythmia
  • With severe psychological symptoms
  • With watery diarrhea
  • Pregnant or lactating women, or women with known or suspected pregnancy
  • Inappropriate patients for entry on this study in the judgment of the investigator
  • With UGT1A1*28 and/or UGT1A1*6 polymorphisms

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Japan9 sites

  • Kansai Medical University

    Hirakata, Osaka

  • Hiroshima University

    Hiroshima

  • Nara Prefectual Medical University

    Kashihara, Nara

  • Kobe University

    Kobe, Hyōgo

  • Nagoya University

    Nagoya, Aichi-ken

  • Osaka City University

    Osaka

  • Osaka Medical Center for Cancer and CVD

    Osaka

  • Osaka University

    Suita, Osaka

  • Wakayama Medical University

    Wakayama, 641-8510

Other trials in Japan

About this study

Official title: The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen

Read the detailed description

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen. The investigators also evaluate the optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic cancer.

Being tested
FIRINOX
Keywords
Borderline resectable pancreatic cancer, R0 resection, Resection rate, Optimal schedule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FIRINOXDrug

    Also called Oxaliplatin, Irinotecan, 5-FU.

    FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.

Study groups in NCT02148549
Study groupRoleWhat they receive
Optimal chemotherapy coursesExperimentalNeoadjuvant chemotherapy 4 courses of FIRINOX early 5 patients, and 8 courses of FIRINOX subsequent 5 patients
Receives: Drug: FIRINOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

    Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.

    Measured: Up to 30 weeks.

Secondary outcomes (3)

  1. The resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

    Measured: Up to 24 weeks.

  2. The R0 resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

    Measured: Up to 30 weeks.

  3. The optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

    Measured: Up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02148549
Sponsor's protocol ID
FIRINOX
Other IDs
UMIN000013809
Acronym
FIRINOX
Status last verified
Jul 2015
First submitted
15 May 2014
Last updated
7 Oct 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FIRINOX in people with Patients With Borderline Resectable Pancreatic Cancer, run by Wakayama Medical University at 9 sites in Japan.

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 9 inclusion and 15 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 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. (time frame: Up to 30 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02148549.

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 7 Oct 2019.

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