NCT01661088

Brief Summary

The investigators hypothesize that the combination of the FOLFIRINOX regimen (a combination of 5-fluorouracil, irinotecan and oxaliplatin chemotherapy) to provide maximal systemic disease control and FDR-gemcitabine chemotherapy with concurrent IMRT (Radiation therapy) to address local disease, will achieve a significant improvement R0 resection (Radiation oncology repeat surgeries) rate in borderline resectable (surgical) pancreatic cancer and enhance disease free and overall survival in this patient population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_2 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2017

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 8, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

November 13, 2019

Status Verified

October 1, 2019

Enrollment Period

6.2 years

First QC Date

July 24, 2012

Results QC Date

June 26, 2018

Last Update Submit

October 29, 2019

Conditions

Pancreatic Cancer

Keywords

Neoadjuvant FOLFIRINOXFDR-GemcitabineConcurrentIMRTBorderline Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Patients That Underwent an R0 Resection

    To determine the frequency of achieving an R0 resection using a neoadjuvant regimen of FOLFIRINOX followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine in patients with borderline resectable pancreatic cancer. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.

    6 months

Secondary Outcomes (2)

  • Median Progression-free Survival Time

    up to 2 years

  • Median Overall Survival Time

    up to 2 years

Study Arms (1)

Study Treatment

EXPERIMENTAL

Patients will receive FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m\^2) on days 1, 8, 22, 29. Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction. Patients without metastatic disease will be offered surgical exploration.

Drug: FOLFIRINOXRadiation: Intensity-modulated radiotherapy (IMRT)Procedure: Surgical Exploration

Interventions

FOLFIRINOXDRUG

Starting dose levels as following: Oxaliplatin 85mg/m2 intravenously over 120 minutes on day 1. Irinotecan 180mg/m2 intravenously over 90 minutes on day 1. NOTE: patients homozygous for the UGT1A1 (TA)7 promoter allele will be treated at an initial lower dose 140mg/m2 (please see Section 6.3.a) Leucovorin 400mg/m2 intravenously over 90 minutes on day 1. 5FU 400mg/m2 as bolus intravenous injection following leucovorin on day 1. 5FU 2,400mg/m2 infused intravenously as a continuous infusion over 46 hours following the bolus 5FU, beginning on day 1.

Study Treatment
Intensity-modulated radiotherapy (IMRT)RADIATION

50.0Gy in 2.0Gy per fraction

Study Treatment
Surgical ExplorationPROCEDURE

Patients without metastatic disease will be offered surgical exploration.

Study Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
  • Patients must be deemed to have borderline resectable disease with no radiologic evidence of distant metastatic disease prior to registration.
  • Specifically, patients must have at least one designation of borderline resectable and no designation of unresectable disease.
  • Patients must have a life expectancy of at least 12 weeks, a Zubrod performance status of \< 1 and be willing and medically able to undergo surgical resection.
  • Patients must have adequate organ function defined as follows: absolute neutrophil count of \> 1500/mm3, platelets \> 100,000/mm3, serum Cr \< 1.5 mg/dl, total bilirubin \< 2.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent).
  • Patients must be free of other active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
  • Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial due to the unacceptable teratogenic toxicity of abdominal radiation and cytotoxic chemotherapy.
  • Patients must be aware of the investigational nature of the therapy and provide written informed consent.

You may not qualify if:

  • Patients with neuroendocrine tumors are excluded.
  • Active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
  • Patients with preexisting peripheral neuropathy \> grade 2 are ineligible
  • Pregnant or nursing women are ineligible.
  • Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
  • Patients may not have used any investigational agent within 4 weeks prior to enrollment into the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Tran NH, Sahai V, Griffith KA, Nathan H, Kaza R, Cuneo KC, Shi J, Kim E, Sonnenday CJ, Cho CS, Lawrence TS, Zalupski MM. Phase 2 Trial of Neoadjuvant FOLFIRINOX and Intensity Modulated Radiation Therapy Concurrent With Fixed-Dose Rate-Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer. Int J Radiat Oncol Biol Phys. 2020 Jan 1;106(1):124-133. doi: 10.1016/j.ijrobp.2019.08.057. Epub 2019 Sep 5.

    PMID: 31494181DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinoxRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Results Point of Contact

Title
Mark Zalupski, M.D.
Organization
University of Michigan Rogel Cancer Center
zalupski@med.umich.edu
734-647-8902

Study Officials

  • Mark Zalupski, MD

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2012

First Posted

August 9, 2012

Study Start

June 1, 2011

Primary Completion

August 10, 2017

Study Completion

August 30, 2019

Last Updated

November 13, 2019

Results First Posted

August 8, 2018

Record last verified: 2019-10

Locations

US(1)