Phase II Neoadjuvant Chemotheraphy (Gemcitabine And Nab-Paclitaxel Vs. MFOLFIRINOX) And Sterotatic Body Radiation Therapy For Borderline Resectable Pancreatic Cancer

Study Overview

Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer

This is a prospective, randomized phase II trial. Patients diagnosed with borderline resectable pancreatic adenocarcinoma will be randomly assigned to one of two treatment arms, either mFOLFIRINOX or gemcitabine and nab-paclitaxel. After three cycles of treatment in the gemcitabine/nab-paclitaxel arm and 6 cycles in the mFOLFIRINOX arm, patients will be restaged with CT scans and if they remain borderline resectable or have improvement of their disease They will then proceed to SBRT followed by surgical resection.

N/A

Borderline Resectable Pancreatic Cancer

DRUG: gemcitabine/nab-paclitaxel
DRUG: mFOLFIRINOX

UPCI 13-143

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-08-29	Results First Submitted 2018-03-05	Last Update Submitted that met QC Criteria 2018-06-30
First Submitted that Met QC Criteria 2014-09-15	Results First Submitted that Met QC Criteria 2018-05-15	Last Update Posted (ACTUAL) 2018-07-26
First Posted (ACTUAL) 2014-09-16	Results First Posted 2018-06-15	Last Verified 2018-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: gemcitabine/nab-paclitaxel three cycles of treatment in the gemcitabine/nab-paclitaxel	DRUG: gemcitabine/nab-paclitaxel three cycles of treatment in the gemcitabine/nab-paclitaxel
EXPERIMENTAL: mFOLFIRINOX 6 cycles in the mFOLFIRINOX	DRUG: mFOLFIRINOX 6 cycles in the mFOLFIRINOX

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: gemcitabine/nab-paclitaxel

three cycles of treatment in the gemcitabine/nab-paclitaxel

DRUG: gemcitabine/nab-paclitaxel

three cycles of treatment in the gemcitabine/nab-paclitaxel

EXPERIMENTAL: mFOLFIRINOX

6 cycles in the mFOLFIRINOX

DRUG: mFOLFIRINOX

6 cycles in the mFOLFIRINOX

Primary Outcome Measures	Measure Description	Time Frame
Safety and Efficacy Using Neo-adjuvant Gemcitabine Plus Nab-paclitaxel in Patients Receiving SBRT and Surgery for Borderline Resectable Pancreatic Cancer, Using Neo-adjuvant mFOLFIRINOX as a Control	Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.	up to 5 years

Secondary Outcome Measures	Measure Description	Time Frame
R0 Resection Rates in Borderline Resectable Pancreatic Cancer		Up to 5 years
Incidence of Grade 3 and 4 Toxicities for the 2 Chemotherapy Regimens That Occur After Cycle 1 Day 1	According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTAE, v4.0)	Up to 5 years
Ca19-9 Response to Neoadjuvant Chemotherapy		Up to 5 years
Time to Disease Progression		Up to 5 years
Measurement of Biomarkers (SPARC, RM1 and SMAD4) in Tissues	This wil be measured in tissues that are obtained at screening and in the resected tumour specimen	Up to 5 years
Radiological Response Rate to Therapy	Radiological improvements will be evaluated by determining changes in density of measurable disease on CT scan pre and post chemotherapy	Up to 5 years
Quality of Life Effects of Chemotherapy on Patients Receiving Chemotherapy and SBRT	This will be measured using the FACT-HB questionaire	Up to 5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically proven adenocarcinoma of the pancreas. If the patient has mixed tumor with predominant adenocarcinoma pathology, they can be enrolled.
Subjects will be staged according to the 2010 American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-4, N0 being eligible; and have a primary tumor of the pancreas (either pancreatic head, neck, uncinate process, or body/tail)
The tumor must be deemed as being borderline resectable. Final CT confirmation of surgical staging/ eligibility will be at the discretion of the pancreatic surgeon of the patient.
Disease is confined to locoregional site as confirmed by the CT and / or diagnostic staging laparoscopy to avoid occult peritoneal deposits. Diagnostic laproscopy will be only if absolutely required
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT
Screening Endoscopic ultrasound if done prior to consent but within 6 weeks of expected randomization date it may be used.
Karnofsky performance status greater than or equal to 70 or Eastern Cooperative Oncology Group (ECOG) performance of 0-2.
Age > 18
Estimated life expectance > 12 weeks
If female patient is of child bearing potential, she must have a negative serum pregnancy test (βhCG) documented up to 72hrs prior to administration of first study drug
Patient has screening blood work performed which includes the following (should be drawn ≤ 14 days prior to randomization)
absolute neutrophil count (ANC) > 1.5 x 109/L
Platelet count ≥ 100000/mm3
Hemoglobin (HgB) ≥ 9g/dL
aspartate aminotransferase (AST),Alanine Aminotransferase (ALT)≤ 2.5 x upper limit of normal (ULN) Total Bilirubin ≤ ULN
Serum Cr within normal limits (WNL)
Coagulation studies with Prothrombin Time and International Normalized Ratio (PT/INR) and partial thromboplastin time (PTT) within normal limits (±15%). • Patient has a urinalysis obtained (≤14 days prior to randomization) and the results are deemed not clinically significant by the investigator.
Patient has no evidence of jaundice at the time of enrolment. If stent is required to alleviate jaundice, it should be metallic. If patient has a previously placed stent and this is plastic, this should be changed to metallic.
Patient's pain symptoms have remained stable with no adjustment to analgesics within 7 days prior to randomization. Patient must be able to swallow entreat medications with no requirement for a feeding tube. Patient's must not have intractable nausea or vomiting which prohibits the patient from oral medications
Diabetes must be controlled prior to enrollment
Disease must be encompassed in a reasonable SBRT "portal" as defined by the treating radiation oncologist

Ineligible Histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas
Evidence of distant metastasis on upright chest x-ray, CT or other staging studies
Subjects with recurrent disease
Prior radiation therapy to the upper abdomen or liver at the discretion of the treating radiation oncologist could impair delivery of the prescribed radiation treatment
Prior chemotherapy
Subjects in their reproductive age who are breast feeding or have a positive pregnancy test
Any co-morbid condition of sufficient severity to limit full compliance with the protocol per assessment by the individual treating physician
Concurrent active infection
Previous or current malignancies of other histologies within the last 3 yrs prior to randomization; with the exception of cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer
Patient with known historical or active infection with HIV, Hepatitis B or Hepatitis C
Patient who has undergone recent major surgery, other than diagnostic surgical procedure within 4 weeks prior to randomization.
Patient who has a history of allergy or hypersensitivity to any of the study drugs.
Patients with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
Patients with greater than 2 screening peripheral neuropathy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record