Birmingham, Alabama 35294


Purpose:

The purpose of this study is to evaluate a new treatment routine for patients with borderline resectable and unresectable pancreas cancers.


Study summary:

We want to find out what effects, good and bad, using chemotherapy combinations modified FOLFIRINOX (Oxaliplatin, Irinotecan, and fluorouracil) OR gemcitabine plus nab-paclitaxel (Gem-ABRAXANE) and radiation using Stereotactic Body Radiation Therapy (SBRT) have on the cancer and to increase the percentage of patients who can have surgery to remove their disease. SBRT is a short course of high dose precisely delivered radiation. The two combination chemotherapy routines (mFOLFIRINOX or GEM-ABRAXANE) have been shown in previous clinical trials to be the most effective FDA approved chemotherapy in wide spread pancreatic cancers. These chemotherapy drugs will be given before the surgery. Radiation Therapy, using the 5 ½ week method as well as SBRT has been used as standard of care and found to be effective to reduce the size of pancreatic cancer, so patients can have surgery. SBRT uses advance techniques to deliver radiation therapy which minimizes the volume of normal tissue receiving high dose radiation while maximizing the dose to the tumor. The use of SBRT spares normal tissue and reduces the side effects of radiation. By being more precise, and using a higher dose of radiation per treatment, the radiation delivery time can be decreased to about one week. When this chemotherapy followed by SBRT is combined in this order, this routine has the potential to treat both the primary disease, as well as to prevent the early spread of disease. It is hoped that the treatment routines in this study will increase the percentage of patients who can proceed to have surgery to remove their tumor. This combination of chemotherapy drugs, mFOLFIRINOX or GEM-ABRAXANE and the sequence of chemotherapy followed by SBRT- the shorter course of radiation has not been studied previously and is considered investigational.


Criteria:

Inclusion Criteria: - Histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled - Subjects will be staged according to the 2010 American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-4, 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/unresectable. Final CT confirmation of surgical staging/eligibility will be at the discretion of the pancreatic surgeon of the patient - Disease must be confined to loco-regional site as confirmed by CT imaging and / or diagnostic staging laparoscopy to avoid occult peritoneal deposits Diagnostic laparoscopy will be performed only if absolutely required - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT - 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 enrollment): - 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 ≤ 1.5 ULN - Serum Cr within normal limits (WNL) - Prothrombin Time and International Normalized Ratio (PT/INR) and Partial Thromboplastin Time (PTT) within normal limits (±15%). - Disease must be encompassed in a reasonable SBRT "portal" as defined by the treating radiation oncologist Exclusion Criteria: - Ineligible Histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas - Patients must not have received prior pancreatic surgery, radiation therapy, chemotherapy or any investigational therapy for pancreatic cancer - Patients with tumors extending or invading duodenum or gastric are not eligible - Evidence of distant metastasis on upright chest x-ray, CT or other staging studies - Subjects with recurrent disease are not eligible - 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 - Patients with scleroderma, ulcerative colitis or other systemic conditions deemed risky for radiation treatment. Therefore, will be excluded. - Prior chemotherapy - Subjects in their reproductive age who are breast feeding or have a positive pregnancy test - Any co-morbid condition such as but not limited to congestive heart failure, cardiac arrhythmia or psychiatric illness of sufficient severity to limit full compliance with the protocol per assessment by the individual treating physician - Concurrent active infection - No prior malignancy allowed except 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 prior to enrollment - 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 grade 2 peripheral neuropathy at the time of enrollment are not eligible


NCT ID:

NCT03641183


Primary Contact:

Principal Investigator
Ravi Kumar Paluri, MD
University of Alabama at Birmingham

Ravikumar Paluri, MD
Phone: 205-934-2992
Email: drravi@uab.edu


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35294
United States

Ravikumar Paluri, MD
Phone: 205-934-2992
Email: rpaluri@uabmc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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