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Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03991962
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this study is to evaluate the efficacy of modified FOLFIRINOX followed by stereotactic body radiotherapy (SBRT) in patients with borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). The primary hypothesis will be to determine if modified FOLFIRINOX followed by SBRT improves progression free survival (PFS) compared to historical controls treated with gemcitabine-based chemotherapy with or without standard fractionated radiation.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: mFOLFIRINOX Radiation: Stereotactic body radiotherapy (SBRT) Phase 2

Detailed Description:

The Primary and Secondary are listed below.

Primary Objective:

- To evaluate progression free survival after modified FOLFIRINOX and SBRT in borderline resectable and locally advanced pancreatic cancer.

Secondary Objective:

  • To evaluate the radiographic response to FOLFIRINOX and SBRT by comparing IV contrast CT scans before and after therapy.
  • To determine rates of recurrence (local only, systemic only, and both local and systemic), and overall survival.
  • To determine rates of grade 3 or greater gastrointestinal toxicity, including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label, single group design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mFOLFIRINOX followed by SBRT
Patients will receive mFOLFIRINOX, followed stereotactic body radiotherapy (SBRT).
Drug: mFOLFIRINOX
Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks

Radiation: Stereotactic body radiotherapy (SBRT)
Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved lymph nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 9 months ]
    Progression-free survival (PFS) at will be judged by CT scan and Response evaluation criteria in solid tumors (RECIST).


Secondary Outcome Measures :
  1. Radiographic Response [ Time Frame: Within 21 days of starting study drug ]
    Radiographic response to FOLFIRINOX and SBRT will be done by comparing IV contrast CT scans before and after therapy.

  2. Rates of Recurrence [ Time Frame: Up to 3 years ]
    Rates of recurrence (local only, systemic only, and both local and systemic) will be monitored for up to 3 years depending on time when the initiation of treatment begins.

  3. Rates of grade 3 or greater gastrointestinal toxicity [ Time Frame: Up to 3 months post treatment ]
    Grade 3 or greater gastrointestinal toxicities will be monitored including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.

  4. Overall Survival [ Time Frame: Up to 3 years ]
    Patients will be monitored for overall survival for up to 3 years depending on time when the initiation of treatment begins.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed pancreatic adenocarcinoma
  • Borderline resectable pancreatic adenocarcinoma or locally advanced pancreatic adenocarcinoma
  • No evidence of extrapancreatic disease on diagnostic imaging
  • No evidence of invasion into the duodenum or stomach, as determined by EGD/EUS
  • No prior treatment (chemotherapy, biological therapy, or radiotherapy) for pancreatic cancer
  • No prior treatment with oxaliplatin, irinotecan, fluorouracil, or capecitabine
  • ECOG Performance Status of 0-1
  • No other malignancy within past five years (exceptions include basal cell carcinoma of the skin, cervical carcinoma in situ, and non-metastatic prostate cancer)
  • No evidence of second malignancy at the time of study entry
  • No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • No > grade 2 sensory peripheral neuropathy
  • No uncontrolled seizure disorder, active neurological disease, or known CNS disease
  • No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
  • Not pregnant and not nursing
  • No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
  • Laboratory parameters as follows:

    • Absolute neutrophil count ≥1,500/uL,
    • Platelet count ≥75,000/uL,
    • Hemoglobin ≥9 g,/dL,
    • Creatinine <1.5 X ULN or estimated GFR >30 ml/min,
    • Bilirubin <1.5 X ULN,
    • AST and ALT <3 X ULN,
    • Negative pregnancy test in women of childbearing potential
  • Able to be treated with SBRT only at the Smilow New Haven campus
  • Able to have fiducials placed in the pancreas

Exclusion Criteria:

  • Failing to meet any of the Inclusion Criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991962


Contacts
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Contact: Kimberly Johung, MD, PhD 203-737-6876 kimberly.johung@yale.edu

Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Kimberly Johung, MD, PhD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03991962     History of Changes
Other Study ID Numbers: 2000024671
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms