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Trial record 17 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

Neoadjuvant Modified FOLFIRINOX in Borderline Resectable Pancreatic Cancer

This study is currently recruiting participants.
Verified March 2017 by Baek-Yeol Ryoo, Asan Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02749136
First Posted: April 22, 2016
Last Update Posted: March 9, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Baek-Yeol Ryoo, Asan Medical Center
  Purpose
The purpose of this study is to assess the feasibility and efficacy outcomes of neoadjuvant modified FOLFIRINOX and postoperative gemcitabine in patients with borderline resectable pancreatic cancer.

Condition Intervention Phase
Pancreatic Adenocarcinoma Drug: Preoperative modified FOLFIRINOX and postoperative gemcitabine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Neoadjuvant Modified FOLFIRINOX in Patients With Borderline Resectable Pancreas Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Baek-Yeol Ryoo, Asan Medical Center:

Primary Outcome Measures:
  • 1-year progression-free survival (PFS) rate [ Time Frame: 1 year ]
    PFS rate at 1 year


Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 3 years ]
    Median PFS

  • Overall survival (OS) [ Time Frame: 3 years ]
    Median OS

  • Macroscopic complete resection rate [ Time Frame: 5 months ]
    The rate of no gross residual disease after surgery

  • Response rate [ Time Frame: 4 months ]
    Response rate defined by Response Evaluation Criteria in Solid Tumor version 1.1

  • Toxicity profile [ Time Frame: 1 year ]
    Adverse events graded by National Cancer Institute Common Terminology Criteria version 4.03

  • Biomarker analysis [ Time Frame: 3 years ]
    Blood-based biomarker analysis for the correlation with response rate, progression-free survival and overall survival


Estimated Enrollment: 44
Study Start Date: May 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perioperative chemotherapy
  • Preoperative mFOLFIRINOX, every 2 weeks, 8 cycles
  • Postoperative gemcitabine, every 4 weeks, 3-6 cycles
Drug: Preoperative modified FOLFIRINOX and postoperative gemcitabine
  • Preoperative mFOLFIRINOX, every 2 weeks, 8 cycles

    • Oxaliplatin IV 85 mg/m2 Day (D) 1
    • Irinotecan IV 180 mg/m2 D1
    • 5-FU continuous IV infusion 2,400 mg/m2 over 46 hours D1-2
    • Leucovorin IV 400 mg/m2 D1
  • Postoperative gemcitabine, every 4 weeks, 3-6 cycles - Gemcitabine 1,000 mg/ m2 D1, 8, and 15

Detailed Description:

Pancreatic cancer is the fourth leading cause of cancer-related death worldwide. The 5-year survival rate in overall patients is less than 6% due to late clinical manifestation and the systemic nature of the disease at presentation. Even in patients with resectable disease, estimated 5-year survival rates after resection are between 15% and 20%. Traditionally, resection alone is regarded as inadequate for cure. Therefore, systemic and/or combined chemotherapy and radiotherapy have been used as preoperative or postoperative therapy.

Neoadjuvant treatment offers several theoretical advantages over an initial resection. Early delivery of systemic therapy for all patients which might lead to the higher rates of negative margin resection rate, and enhanced patient selection for surgery. Although neoadjuvant treatment has been established as a standard of care for resectable or locally advanced disease of breast, gastric, and rectal cancers, the role of neoadjuvant treatment in patients with pancreatic cancer is not clear at present.

There is no global consensus on the management of patients with borderline resectable pancreatic cancer. If initially resected, postoperative adjuvant chemotherapy or chemoradiotherapy is standard. However, there is no standard regimen for neoadjuvant chemotherapy for pancreatic cancer. Recent pivotal phase 2/3 trial has demonstrated that FOLFIRINOX improved the response rates and survival outcomes of patients with metastatic pancreatic cancer compared to gemcitabine.

Because of higher response rates (about 30%) with FOLFIRINOX, this regimen is now widely investigated in the neoadjuvant setting. Therefore, investigators hypothesize that neoadjuvant FOLFIRINOX may enhance the outcomes of patients with borderline resectable pancreatic cancer. This study will assess the feasibility and efficacy outcomes of neoadjuvant modified FOLFIRINOX and postoperative gemcitabine in patients with borderline resectable pancreatic cancer.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 19 years and older
  • Cytologically or histologically confirmed adenocarcinoma of the pancreas
  • Met the NCCN criteria for borderline resectable disease (assessed at Aug 23rd, 2015)
  • No previous chemotherapy or radiotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 1
  • Adequate bone marrow function as defined by platelets ≥ 100 x 109/L and neutrophils ≥ 1.5 x 109/L
  • Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN)
  • Adequate hepatic function with serum total bilirubin < 2 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN
  • No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other non life-threatening cancer (i.e., prostate or thyroid cancer) except where treated with curative intent > 5 years previously without evidence of relapse
  • Written informed consent to the study

Exclusion Criteria:

  • No potentially resectable disease or no metastatic disease
  • Locally advanced unresectable disease according to the NCCN criteria
  • Histologically confirmed adenosquamous carcinoma
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance
  • Last dose of radiotherapy received within 4 weeks before the start of study treatment, excluding palliative radiotherapy
  • Obstruction of gastrointestinal tract
  • Active gastrointestinal bleeding
  • Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
  • Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol
  • Female subjects who are pregnant or lactating, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving study drug until 3 months after receiving the last dose of study drug. A highly effective method of contraception is defined as having a low failure rate (< 1% per year) when used consistently and correctly.
  Contacts and Locations
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): NCT02749136


Contacts
Contact: Baek-Yeol Ryoo, MD, PhD +82-2-3010-3211 ryooby@amc.seoul.kr
Contact: Changhoon Yoo, MD +82-10-9900-6798 yooc@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 05505
Contact: Changhoon Yoo, MD    +82-2-3010-1727    yooc@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Baek-Yeol Ryoo, MD, PhD Asan Medical Center
  More Information

Publications:

Responsible Party: Baek-Yeol Ryoo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02749136     History of Changes
Other Study ID Numbers: AsanONCHBP-2015-001
First Submitted: April 20, 2016
First Posted: April 22, 2016
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Baek-Yeol Ryoo, Asan Medical Center:
Pancreatic adenocarcinoma
Borderline resectable
Neoadjuvant chemotherapy
FOLFIRINOX

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs