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Pancreatic CancerPhase 3NCT01926197

Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer

A Phase 3 study testing Oxaliplatin, Irinotecan and Leucovorin in people with Pancreatic Cancer, run by Stanford University at 9 sites in 2 countries.

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

The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Oxaliplatin, Irinotecan and Leucovorin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
9 sitesin 2 countries
Study dates
14 Aug 2013to 30 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically-confirmed adenocarcinoma of the pancreas
  • Determined unresectable by a pancreatic cancer surgeon or a multi-disciplinary or gastrointestinal oncology Tumor Board.
  • Stable or better disease on re-staging scans
  • Typically, tumors < 8.0 cm in greatest axial dimension but final determination of eligibility based upon radiation normal tissue constraints
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
  • Leukocytes (white blood cells, WBC) ≥ 3,000/mL
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  • Absolute neutrophil count (ANC) ≥ 1,500/mL
  • Platelets ≥ 50,000/mL
  • Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 X institutional ULN
  • Creatinine within normal institutional limits
  • Ability to understand and the willingness to sign an informed consent form
  • Life expectancy > 6 months

Who cannot join

  • Metastatic disease
  • Prior radiotherapy to the upper abdomen/liver.
  • Prior chemotherapy for pancreatic cancer, other than up to 4 cycles of modified FOLFIRINOX.
  • Age < 18 years
  • Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection (or infections requiring systemic antibiotic treatment)
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  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trial.
  • Pregnant or lactating
  • Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) for duration of the study
  • Women who are not post-menopausal (as defined in Appendix III) and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
  • Male subjects who are unwilling or unable to use effective contraception for duration of the study

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States7 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • UCLA

    Los Angeles, California, 60153

  • Loyola University

    Maywood, Illinois, 60153

  • UCSF

    San Francisco, California, 94143

  • Swedish Cancer Institute

    Seattle, Washington, 98107

  • Stanford University, School of Medicine

    Stanford, California, 94305

Other trials in United States

Canada2 sites

  • Princess Margaret Cancer Centre

    Toronto, Ontario

  • BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) With or Without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer: A Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial

The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.

Read the detailed description

Primary Objective:

To determine progression free survival for mFFX +/- SBRT.

Secondary Objectives:

  • To determine metastasis free survival following mFFX chemotherapy alone or with SBRT.
  • To determine the overall survival in pancreatic cancer patients treated with chemotherapy +/- SBRT.
  • To determine local progression-free survival in pancreatic cancer patients after chemotherapy +/- SBRT.
  • To evaluate acute (within 3 months of treatment) grade 2 or greater gastritis, fistula, enteritis, or ulcer and any other grade 3-4 gastrointestinal toxicity within 3 months of treatment.
  • To evaluate the utility of FDG-PET for treatment planning and estimation of progression free survival.
  • To identify new biomarkers in pancreatic cancer.
  • To evaluate the quality of life of patients before and after either chemotherapy or chemotherapy and SBRT.
Being tested
Oxaliplatin, Irinotecan, Leucovorin, 5FU, Stereotactic Body Radiotherapy (SBRT)
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • OxaliplatinDrug

    Also called Eloxatin

    Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.

  • IrinotecanDrug

    Also called Camptosar, Camptothecin-11 (CPT-11), Campto, Onivyde

    Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.

  • LeucovorinDrug

    Also called Folinic acid, Wellcovorin, Citrovorum Factor

    Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.

  • 5FUDrug

    Also called 5-fluorouracil, Tolak, Fluoroplex, Efudex

    5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.

  • Stereotactic Body Radiotherapy (SBRT)Radiation

    Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.

Study groups in NCT01926197
Study groupRoleWhat they receive
Modified FOLFIRINOXActive comparatorModified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
Receives: Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin; Drug: 5FU
Modified FOLFIRINOX plus Stereotactic Body RadiotherapyExperimentalModified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
Receives: Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin; Drug: 5FU; Radiation: Stereotactic Body Radiotherapy (SBRT)

What is being measured

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

  1. Progression-free Survival (PFS)

    Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the median PFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.

    Measured: 38 months

Secondary outcomes (5)

  1. Local Progression-free Survival (Local PFS)

    Local progression-free survival (PFS) means the period of time that a participant remains alive without recurrence or advancement of the disease at the baseline sites of the tumor (local progression). The effect of the study treatments was assessed as the median local PFS of participants in the treatment groups. The outcome is reported as the median local PFS with standard deviation.

    Measured: 38 months

  2. Progression-free Survival (PFS) at 1 Year

    Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the number of participants in each treatment group that remained alive without tumor progression, at 1 year after treatment.

    The outcome is reported as a number without dispersion.

    Measured: 1 year

  3. Metastasis-free Survival (MFS)

    Metastasis-free survival (MFS) means the period of time that a participant remains alive without the appearance of new tumor lesions a distant site in the body (metastasis). The effect of the study treatments was assessed as the median MFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.

    Measured: 62 months

  4. Overall Survival (OS)

    The effect of the study treatments was assessed as the length of time participants in each treatment group that remained alive. The outcome is reported as the median OS with standard deviation.

    Measured: 62 months

  5. Grade 2 or Greater Gastrointestinal (GI) Toxicity

    Toxicity means an adverse event related to the study treatment. Toxicity was assessed between treatment groups as the number of treatment-related , ≥ grade 2 events of gastritis, fistula, enteritis, or ulcer; plus any other Grade 3 to 5 gastrointestinal (GI) toxicity. The outcome is reported as the number of defined adverse events by preferred term for each treatment group, occurring within 3 months of the start of treatment. These adverse events by definition are all within the Common Terminology Criteria for Adverse Events (CTCAE) version 4.01 Gastrointestinal Body System. The outcome is reported as numbers without dispersion.

    All-cause Mortality mFFX 7 SBRT 8

    Measured: 3 months

Timeline

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

  1. First posted20 Aug 2013 (estimated)
  2. Study start14 Aug 2013
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2022

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01926197
Sponsor's protocol ID
IRB-27492
Other IDs
PANC0015, NCI-2013-01658
Status last verified
Oct 2022
First submitted
15 Aug 2013
Last updated
28 Oct 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxaliplatin, Irinotecan and Leucovorin in people with Pancreatic Cancer, run by Stanford University at 9 sites in 2 countries.

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 13 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 28 Oct 2022. 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 United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival (PFS) (time frame: 38 months). 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 NCT01926197.

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 28 Oct 2022.

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