Neoadjuvant Therapy Followed by Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Pancreatic Cancer

STATUS

Recruiting
participants needed

30
sponsor

University of Alabama at Birmingham

Send

Updated on 8 November 2020

See if I qualify

platelet count

paclitaxel

measurable disease

karnofsky performance status

neutrophil count

gemcitabine

thromboplastin

cancer chemotherapy

adenocarcinoma

folfirinox

pancreatic neoplasm

Summary

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

Description

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 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.

Details

Condition	Pancreatic Cancer
Treatment	FOLFIRINOX Drugs, Gemcitabine-nab Paclitaxel
Clinical Study Identifier	NCT03641183
Sponsor	University of Alabama at Birmingham
Last Modified on	8 November 2020

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
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 (hCG) 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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

0/250

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

platelet count

paclitaxel

measurable disease

karnofsky performance status

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Edit Delete

Added by •

•

Private

Edit Delete

Reply by • • Private

Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

Enter the passcode

The passcode will expire in None.

Neoadjuvant Therapy Followed by Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Pancreatic Cancer