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Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02839343
Recruitment Status : Active, not recruiting
First Posted : July 20, 2016
Results First Posted : May 24, 2022
Last Update Posted : May 24, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Sky Foundation
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief Summary:
This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with or without hypofractionated radiation therapy before surgery works in patients with pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is more effective with or without hypofractionated radiation therapy before surgery in treating patients with pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Borderline Resectable Adenocarcinoma of the Head of the Pancrease Radiation: radiation therapy Procedure: surgery Drug: mFOLFIRINOX Drug: FOLFOX Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas
Actual Study Start Date : December 2016
Actual Primary Completion Date : November 30, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: mFOLFIRINOX + surgery + FOLFOX
Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
 Procedure: surgery
Drug: mFOLFIRINOX
oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV

Drug: FOLFOX
oxaliplatin IV, leucovorin IV and 5-FU IV
Experimental: mFOLFIRINOX + radiation + surgery + FOLFOX
Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
 Radiation: radiation therapy
Procedure: surgery
Drug: mFOLFIRINOX
oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV

Drug: FOLFOX
oxaliplatin IV, leucovorin IV and 5-FU IV


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) Rate [ Time Frame: 18 months ]
    Defined as the percentage of patients who are alive at 18 months after randomization divided by the total number of evaluable patients in each arm. An evaluable patient is defined as any patient who signed informed consent, deemed eligible by central review and received any protocol-defined treatment. 95% confidence interval will be estimated based on standard method. Chi-squared test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare 18 month OS rates among treatment arms. OS within each arm will be summarized by Kaplan-Meier method. Median, 1-year and 2-year rates will be estimated based on Kaplan-Meier curves.


Secondary Outcome Measures :
  1. Residual Tumor (R)0 Resection Rate [ Time Frame: 24 months ]
    Defined as the percentage of patients in whom an achieved R0 resection was achieved during surgery.

  2. Event-free Survival [ Time Frame: 4 years and 7 months ]
    Defined as time from randomization to the first documentation of event where events considered are 1) disease progression, per RECIST, prior to surgery, 2) surgery with R2 resection, 3) recurrent disease following surgery, or 4) death due to any cause. Will be estimated using the method of Kaplan-Meier in each arm and compared between treatment groups using the log-rank test. The correlation between pathologic complete response (pCR) status and event-free survival time will be assessed by Cox model with landmark approach.

  3. Pathologic Complete Rate (pCR) Rate [ Time Frame: 24 months ]
    Defined as the percentage of patients in whom a pCR was confirmed by histopathologic review of the surgical specimen. Chi-square test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare pCR resection rate between two treatment arms. Sensitivity analysis will be conducted among patients in cohort 1) and cohort 2). The association between pCR rate and OS/progression free survival (PFS) will be assessed by log-rank test and Cox model.

  4. Incidence of Adverse Events Assessed Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4 and the Patient-Reported Outcomes Version of the CTCAE [ Time Frame: 1 year ]
    Overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse).


Eligibility Criteria
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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:

  • Confirmation of radiographic stage as borderline resectable disease by real-time Alliance central radiographic review
  • No prior chemotherapy or radiation for pancreatic cancer
  • No definitive resection of pancreatic cancer
  • Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
  • No grade >= 2 neuropathy
  • No known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism
  • No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease) within 28 days of registration
  • Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Creatinine =< 1.5 x upper limit of normal (ULN) or
  • Calculated (calc.) creatinine clearance > 45 mL/min
  • Total bilirubin =< 2.0 mg/dL
  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 X upper limit of normal (ULN)
Contacts and Locations
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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): NCT02839343


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Sky Foundation
Investigators
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Study Chair: Matthew Katz, MD, FACS The University of Texas MD Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by Alliance for Clinical Trials in Oncology:
Study Protocol and Statistical Analysis Plan  [PDF] October 19, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02839343    
Other Study ID Numbers: A021501
NCI-2016-00456 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Posted: July 20, 2016    Key Record Dates
Results First Posted: May 24, 2022
Last Update Posted: May 24, 2022
Last Verified: April 2022
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms