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Pancreatic CancerPhase 2NCT04130399

Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer

A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) and FOLFIRINOX in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by Indiana University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to research the effects of delivering full-dose neoadjuvant multi-agent chemotherapy (folfirinox) followed by stereotactic body radiation therapy (SBRT) in patients with resectable pancreatic ductal adenocarcinoma (PDAC) in order to intensify local therapy and improve outcomes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer, Pancreatic Adenocarcinoma
What is being tested?
Stereotactic Body Radiation Therapy (SBRT) and FOLFIRINOX
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jul 2019to 1 Jan 2023
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

  • Age ≥ 18 years
  • Pathologic confirmation of pancreatic ductal adenocarcinoma
  • Resectable disease (determined by treating surgeon)
  • Patients planning to receive neoadjuvant Folfirinox as part of their standard of care treatment
  • No evidence of distant organ metastatic disease
  • Eastern Cooperative Oncology Group Performance status 0-1
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  • Ability to understand and the willingness to sign informed consent document
  • Adequate organ function, defined by the following laboratory values, at the time of study entry:
  • Hemoglobin ≥ 10 g/dL (transfusions acceptable)
  • Absolute Neutrophil Count ≥ 0.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Creatinine ≤ 1.5x institutional upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min
  • Total bilirubin ≤ 2x institutional ULN
  • Aspartate aminotransferase test (AST)/ Alanine Aminotransferase Test (ALT) ≤ 3x institutional ULD

Who cannot join

  • Severe/uncontrolled intercurrent illness that, in the opinion of the patient's treating physicians, would prevent the patient from receiving either multi agent chemotherapy, high-dose radiation, or undergoing resection of the pancreatic tumor
  • Prior therapy for PDAC
  • Prior radiation to the upper abdomen (RT to other sites acceptable)
  • Inability to undergo port or PICC line placement
  • Active gastric or duodenal ulcer
  • Tumor invasion of the intestinal or gastric lumen
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  • Active hepatitis B or other active serious infections
  • Pregnant and breastfeeding women are excluded. Women of child-bearing potential must have a negative urine or serum pregnancy test and be willing to use acceptable methods of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study treatment
  • Life expectancy of < 3 months
  • Patients with contraindications to either PET scan or MRI (e.g., pacemaker/ICD) will NOT be excluded from study participation. Such patients will be treated per protocol but will not be required to undergo PET-MRI.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Melvin & Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

The purpose of this study is to research the effects of delivering full-dose neoadjuvant multi-agent chemotherapy (folfirinox) followed by stereotactic body radiation therapy (SBRT) in patients with resectable pancreatic ductal adenocarcinoma (PDAC) in order to intensify local therapy and improve outcomes.

Read the detailed description

Primary Objectives:

  1. To assess one-year local control rates in patients with operable PDAC who receive neoadjuvant chemotherapy and SBRT

Secondary Objectives:

  1. To assess the following disease control endpoints: pathological response, disease-free survival, overall survival, failure pattern (local vs. distant) and time to development of distant metastases
  2. To assess safety of the SBRT regimen

Exploratory objectives

  1. To obtain exploratory data correlating tumor response grade with changes in circulating tumor DNA levels following chemotherapy, SBRT, and surgery in patients with PDAC
  2. To obtain exploratory data correlating circulating tumor DNA (ctDNA) changes with disease control endpoints (overall survival, disease-free survival, failure pattern, and time to development of distant metastases)
  3. To obtain exploratory data on positron emission tomography (PET) and magnetic resonance imaging (MRI) findings and correlations with tumor response among patients treated on study.
Being tested
Stereotactic Body Radiation Therapy (SBRT), FOLFIRINOX
Keywords
Folfirinox, Cancer, Radiation Therapy, neoadjuvent chemotherapy, Stereotactic Body Radiation Therapy (SBRT)
Medical subject headings
Pancreatic Neoplasms, Neoplasms

What participants receive

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

  • Stereotactic Body Radiation Therapy (SBRT)Radiation

    Patients will receive 5 fractions of SBRT delivered over a five-day period. Treatment may be delivered over 2 weeks, provided that the patient receives at least 2 fractions per week.

  • FOLFIRINOXDrug

    Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines

Study groups in NCT04130399
Study groupRoleWhat they receive
Preoperative Chemotherapy + SBRTExperimentalParticipants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines. After 6 cycles of neoadjuvant therapy are completed, patients will undergo imaging with pancreatic protocol CT and PET-MRI to assess disease status . Patients without evidence of disease progression at the end of 6 cycles of neoadjuvant treatment will proceed to SBRT followed by surgical resection. Following surgery, patients will receive an additional 6 cycles of FOLFIRINOX chemotherapy.
Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: FOLFIRINOX

What is being measured

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

  1. Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT

    Measured: 1 year after surgery date

Secondary outcomes (8)

  1. Pathological tumor response grade

    Measured: Surgery Date (4 weeks [+/- 14 days] from end of SBRT)

  2. Rate of margin negative resection

    Measured: Surgery Date (4 weeks [+/- 14 days] from end of SBRT)

  3. Rate of progression free survival

    Measured: From surgery date to first documented date of progression, up to 5 years

  4. Overall survival

    Measured: From surgery date to date of death, up to 5 years

  5. Local control rate

    Measured: from date of surgery until date of first documented local failure, up to 5 years

  6. Time to development of distant metastases

    Measured: From surgery date to date of first documented metastatic disease, up to 5 years

  7. Site of first failure

    Measured: From surgery date to date of first documented metastatic disease, up to 5 years

  8. Rate of grade 3-4 non hematological toxicity rates

    Measured: Date of first fraction of SBRT through 30 days (+/-14) after surgery date

Timeline

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

  1. First posted17 Oct 2019
  2. Study start1 Jul 2019 (estimated)
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Jan 2023 (estimated)

Why it stopped: Study is being abandoned.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
preoperative chemotherapy with FOLFIRINOX followed by SBRT in patients with resectable pancreatic cancer.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04130399
Sponsor's protocol ID
IUSCC-0686
Status last verified
Sep 2019
First submitted
15 Oct 2019
Last updated
17 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) and FOLFIRINOX in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by Indiana University at 1 site in United States.

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 14 inclusion and 10 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: withdrawn, as of the sponsor's last update on 17 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 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.

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?

Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT (time frame: 1 year after surgery date). 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 NCT04130399.

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 17 Oct 2019.

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