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Gemcitabine/Nab-Paclitaxel With HIGRT in 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. Read our disclaimer for details. Identifier: NCT02318095
Recruitment Status : Active, not recruiting
First Posted : December 17, 2014
Last Update Posted : February 15, 2019
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE December 12, 2014
First Posted Date  ICMJE December 17, 2014
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE February 17, 2015
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2014)
Feasibility of neoadjuvant gemcitabine/nab-paclitaxel and HIGRT in patients with potentially resectable pancreatic cancer. [ Time Frame: 3 years ]
The neoadjuvant regimen will be considered feasible if (a) the trial can accrue 25 patients in no more than 3 years and (b) if at least 18 of the 25 patients adhere to the neoadjuvant regimen.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2014)
  • Grade >/=2 acute toxicity [ Time Frame: Baseline to 60 days post surgery ]
    CTCAE version 4 will be used for all toxicity assessments. The acute toxicity rate, defined as any non-hematologic grade 2+ toxicity occurring during treatment through 60 days post-treatment, will be estimated with its exact 80% confidence interval. Likewise, we will determine the rate of grade 2+ hematologic toxicity occurring during treatment through 60 days post treatment and the proportion of patients requiring treatment breaks longer than 5 days.
  • Resection rate [ Time Frame: Post surgery ]
    Patients who undergo surgical resection will be documented
  • R0 resection rate [ Time Frame: 14-30 days post surgery ]
    Pathologic review will determine if an R0 resection has been performed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer
Official Title  ICMJE Feasibility Study of Neoadjuvant Gemcitabine/Nab-Paclitaxel and Hypofractionated Image-Guided Intensity Modulated Radiotherapy in Resectable and Borderline Resectable Pancreatic Cancer
Brief Summary This research protocol will evaluate the feasibility of administering neoadjuvant gemcitabine and nab-paclitaxel with hypofractionated, image guided, intensity modulated radiotherapy (HIGRT) in resectable and borderline resectable pancreatic cancer
Detailed Description

Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and accounts for roughly 40,000 deaths each year. Despite the use of neoadjuvant and adjuvant therapies, little progress has been made in the the last three decades, and the search for more efficacious treatment continues.In patients with a good performance status the combination of effective systemic therapy with gemcitabine/nab-paclitaxel and high dose local radiotherapy may improve disease outcomes. This is a prospective, single arm study in patients in newly diagnosed, previously untreated pancreatic cancer who are planned to undergo surgical resection The primary objective of this study is to evaluate the toxicity of a neoadjuvant approach incorporating gemcitabine/nab-paclitaxel and Hypofractionated image guided intensity-modulated radiotherapy (HIGRT) prior to surgical resection. Eligible subjects will recieve standard neoadjuvant gemcitabine and nab-paclitaxel dosing is as follows:Nab-Paclitaxel (125mg/m2) days 1,8,15 every 28 days for 2 cycles Gemcitabine (1000mg/m2) days 1,8,15 every 28 days for 2 cycles followed by HIGRT and surgical resection.

Adjuvant chemotherapy may be given post surgery at the discretion of the treating medical oncologist.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Resectable Pancreatic Cancers
Intervention  ICMJE
  • Drug: Gemcitabine/nab-Paclitaxel
    Prospective, single arm study ; eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel. All chemotherapy administered to study subjects is standard of care. The chemotherapy combination, gemcitabine/nab-paclitaxel, is considered to be a standard-of-care, non-investigational chemotherapy combination; chemotherapy dosing and treatment schedule will be managed by the treating medical oncologist. Restaging will be completed post chemotherapy.
  • Radiation: Radiation therapy
    5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.
  • Other: Sugical resection
    Surgical resection of the pancreas post radiation therapy
  • Drug: Adjuvant chemotheapy
    Adjuvant chemotherapy may be given after surgery at the clinical discretion of the medical oncologist
Study Arms  ICMJE Chemotherapy/radiation/surgery
This is a single arm prospective study. All eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist.
  • Drug: Gemcitabine/nab-Paclitaxel
  • Radiation: Radiation therapy
  • Other: Sugical resection
  • Drug: Adjuvant chemotheapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 19, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2014)
Estimated Study Completion Date  ICMJE January 2020
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient has signed informed consent and is willing to comply with the protocol
  2. Histologically or cytologically proven adenocarcinoma of the pancreas (within the last 90 days)
  3. Either resectable or borderline resectable as determined on staging imaging (as defined by National Comprehensive Cancer Network [NCCN])
  4. Patient is 18 years or older
  5. Karnofsky performance status 70 or greater
  6. The ANC count ≥ 1500, the platelet count ≥ 100,000 and hemoglobin ≥ 9g/dL
  7. Laboratory values meet the following constraints: Bilirubin less than or equal to 2 mg/dL; AST and ALT less than or equal to 3 x ULN (stenting to improve biliary obstruction is permitted)
  8. No evidence of metastatic disease based on imaging of the chest, abdomen and pelvis.

Exclusion Criteria:

  1. Metastatic disease on pretreatment imaging
  2. Prior systemic therapy
  3. Prior abdominal radiation. Any prior radiation must be approved by the Radiation Oncology PI
  4. Previous treatment for pancreatic cancer
  5. Patients with any serious/poorly controlled medical or psychological conditions that would be exacerbated by treatment, would complicate protocol compliance
  6. Pregnant or lactating. Adequate birth control must be used if child bearing potential as outlined in the protocol. Negative pregnancy test in female patients of child-bearing potential per institutional policy . Post-menopausal women must have had amenorrhea for at least 18 months to be considered non-child bearing
  7. Clinically significant peripheral vascular disease
  8. Presence of active or chronic infection
  9. Clinically significant atherosclerotic cardiovascular disease including patients with New York Heart Class II/III/IV CHF, ventricular arrhythmias requiring medication, myocardial infarction, cerebrovascular accident, transient ischemic attack, coronary artery bypass grafting, angioplasty, cardiac or other vascular stenting within the past 6 months
  10. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within six months prior to treatment start
  11. History of collagen vascular disease or inflammatory bowel disease (Crohn's or ulcerative colitis)
  12. Current grade 2 or higher peripheral neuropathy
  13. Anticoagulation with warfarin
  14. History of arterial thromboembolic events or symptomatic pulmonary embolism within the past 6 months
  15. Active bleeding diathesis or history of major bleeding, CNS bleeding, or significant hemoptysis within the past 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02318095
Other Study ID Numbers  ICMJE Pro00058865
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manisha Palta, MD Duke University Health System
PRS Account Duke University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP