Neoadjuvant Modified FOLFIRINOX in Borderline Resectable 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02749136|
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: Preoperative modified FOLFIRINOX and postoperative gemcitabine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Neoadjuvant Modified FOLFIRINOX in Patients With Borderline Resectable Pancreas Adenocarcinoma|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||June 2019|
Experimental: Perioperative chemotherapy
Drug: Preoperative modified FOLFIRINOX and postoperative gemcitabine
- 1-year progression-free survival (PFS) rate [ Time Frame: 1 year ]PFS rate at 1 year
- 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
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
|Contact: Baek-Yeol Ryoo, MD, PhDemail@example.com|
|Contact: Changhoon Yoo, MDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Baek-Yeol Ryoo, MD, PhD||Asan Medical Center|