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Resectable Pancreatic CancerEarly Phase 1GCC 1324NCT01992705

Borderline Pancreas Study: FOLFIRINOX +SBRT

A Early Phase 1 study testing Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable, -Oxaliplatin 85 mg/m2 IV on Day 1 and -Irinotecan 180 mg/m2 IV on Day 1 in people with Resectable Pancreatic Cancer, run by University of Maryland, Baltimore at 1 site in United States.

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

Primary Objective: To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy. Secondary Objective(s): 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Resectable Pancreatic Cancer
What is being tested?
Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable, -Oxaliplatin 85 mg/m2 IV on Day 1 and -Irinotecan 180 mg/m2 IV on Day 1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Mar 2014to 27 Sep 2018
Phase
Early 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years at diagnosis.
  • Biopsy proven pancreatic adenocarcinoma.
  • Borderline resectable per NCCN criteria (No distant metastases, venous involvement of the portal vein/SMV, demonstrating tumor abutment and narrowing of the lumen, encasement of the portal vein/SMV without encasement of the nearby arteries, or short-segment venous occlusion resulting from either tumor thrombus or encasement but with suitable vessel proximal or distal to this area of vessel involvement, allowing for safe resection and reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; tumor abutment of the SMA not to exceed 180 degrees of the circumference of the vessel wall.).
  • Radiologically measurable or clinically evaluable disease.
  • Pancreas protocol CT and/or MRI if required for further clarification of disease tissue planes within 4 weeks of registration.
  • ECOG PS of 0-2.
Show all 21Show fewer
  • Able to get a Whipple resection per surgeon assessment performed within 4 weeks of registration.
  • The following laboratory values obtained ≤ 28 days prior to registration:
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3.
  • Platelet count ≥ 100,000/mm3.
  • Hemoglobin > 8.0 g/dL.
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
  • SGOT (AST) ≤ 2 x ULN.
  • SGPT (ALT) ≤ 2 x ULN.
  • Creatinine ≤ 1.5 x ULN.
  • CA 19-9 level (to establish baseline).
  • A negative pregnancy test within 7 days prior to registration for women of childbearing potential. In addition, male and female participants must commit to adequate contraception while on study.
  • Able to provide written informed consent.
  • Willing to return for all required study assessments.
  • Neurological assessment for pre-existing peripheral neuropathy.
  • Documentation of pre-existing hearing deficits.

Who cannot join

  • Any pancreatic adenocarcinoma that does not meet criteria for borderline resectable disease.
  • Prior history of abdominal radiation therapy.
  • History of autoimmune disease such as scleroderma, lupus, and inflammatory bowel disease.
  • Patients with tumor-caused symptomatic bowel obstruction.
  • Chemotherapy (including hormonal therapy) within the past 5 years from date of registration.
  • Other invasive malignancies within the past 5 years from date of registration.
  • Pregnant or nursing women or women of childbearing age that are unwilling to employ adequate contraception.
  • Other co-morbid conditions which, based on the judgment of the physicians obtaining informed consent, would make the patient inappropriate for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Neoadjuvant FOLFIRINOX and Stereotactic Body Radiotherapy (SBRT) Followed by Definitive Surgery for Patients With Borderline Resectable Pancreatic Adenocarcinoma: A Single-Arm Pilot Study

Primary Objective: To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy.

Secondary Objective(s):

  1. To assess the disease-free-survival, overall survival, time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT
  2. To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer
  3. To determine the radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy
  4. To assess quality of life through and after treatment using the FACT-Hep questionnaire
Read the detailed description

The study investigators hypothesize that neoadjuvant FOLFIRINOX can be safely and efficaciously delivered using a sequential regimen with SBRT as an alternative to standard neoadjuvant chemoradiotherapy. Standard of care neoadjuvant treatment typically requires about six weeks of treatment with sub-systemic dosing of chemotherapy. The feasibility of the sequential delivery of the FOLFIRINOX followed by SBRT will be evaluated by capturing the prevalence of grade 3 toxicity and the treatment delay rate.

In our study, SBRT is planned sequentially to follow cycle 4 of chemotherapy treatment, provided toxicity has resolved to grade 2 or less. Thus, allowing for resolution of chemotherapy toxicity prior to initiation of radiation therapy. This interval and the fact that there is no concurrent delivery of chemo-RT, based on previously discussed experiences, including approaches where SBRT safely follows other intense chemotherapy regimens (see Polistina et al and Chuong [35,36]) makes this study feasible without establishing toxicity profile.

The proposed regimen of 4 cycles of FOLFIRINOX followed by 30 Gy/5 fractions using SBRT will be safely tolerated and will improve resectability rates in borderline resectable PDAC patients. In addition, this regimen will not compromise the ability to achieve a successful Whipple resection.

This regimen will improve the local control rate and overall disease free survival in this patient population. The investigators further hypothesize that early administration of FOLFIRNOX will provide optimal systemic therapy to control clinically occult micrometastases.

Being tested
Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable, -Oxaliplatin 85 mg/m2 IV on Day 1, -Irinotecan 180 mg/m2 IV on Day 1, -5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours
Keywords
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.

  • Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicableOther

    Patients will receive chemotherapy (21d/cycle for a total of 4 cycles) plus SBRT before screening for surgical resection of the pancreas.

  • -Oxaliplatin 85 mg/m2 IV on Day 1Drug

    Oxaliplatin 85 mg/m2 IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles).

  • -Irinotecan 180 mg/m2 IV on Day 1Drug

    Irinotecan 180 mg/m2 IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles).

  • -5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hoursDrug

    5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours of each cycle (21d/cycle for a total of 4 cycles.

Study groups in NCT01992705
Study groupRoleWhat they receive
Chemotherapy+SBRT prior to surgery if applicableOtherFOLFIRINOX Drugs: * Calcium Folinate (Folinic Acid) 400 mg IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles. Stereotactic Body Radiotherapy (SBRT): 30 Gy in 5 fractions given to radiographically defined pancreatic mass alone
Receives: Other: Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable; Drug: -Oxaliplatin 85 mg/m2 IV on Day 1; Drug: -Irinotecan 180 mg/m2 IV on Day 1; Drug: -5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours

What is being measured

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

  1. Rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy.

    To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy (AGGC 6th edition).

    Measured: Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first.

Secondary outcomes (1)

  1. Survival status (disease-free-survival vs. overall survival) time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT

    To assess the disease-free-survival, overall survival, time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT (RECIST)

    Measured: Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first.

Timeline

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

  1. First posted25 Nov 2013 (estimated)
  2. Study startMar 2014
  3. Primary completion27 Sep 2018
  4. Study completion27 Sep 2018

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01992705
Sponsor's protocol ID
HP-00055716
Acronym
GCC 1324
Status last verified
Aug 2019
First submitted
27 Sep 2013
Last updated
19 Aug 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable, -Oxaliplatin 85 mg/m2 IV on Day 1 and -Irinotecan 180 mg/m2 IV on Day 1 in people with Resectable Pancreatic Cancer, run by University of Maryland, Baltimore 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 21 inclusion and 8 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 19 Aug 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy. (time frame: Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first.). 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 NCT01992705.

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 19 Aug 2019.

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