Margin-Intense Combo Therapy In Pts W/Potentially Resectable Pancreatic Cancer

Study Overview

Margin-Intense Combo Therapy in Pts w/Potentially Resectable Pancreatic Cancer

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic body radiation therapy together with gemcitabine hydrochloride may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of stereotactic body radiation therapy when given with or without gemcitabine hydrochloride in treating patients with pancreatic cancer that can be removed by surgery.

OBJECTIVES: * To demonstrate the feasibility and safety of administering margin-intensive stereotactic body radiotherapy together with preoperative gemcitabine hydrochloride to patients with resectable pancreatic adenocarcinoma. OUTLINE: This is a multicenter, dose-escalation study of gemcitabine hydrochloride. Patients receive 1 of 2 treatment regimens. * Regimen 1: Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43. * Regimen 2: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Patients undergo a single fraction of SBRT between days 21-28 followed by pancreatoduodenectomy between days 35-63. After completion of study treatment, patients are followed periodically for 5 years.

Pancreatic Cancer

DRUG: gemcitabine hydrochloride
RADIATION: stereotactic body radiation therapy

SCCC-01209
CDR0000657523 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))
NCI-2011-01117 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trials Reporting System))

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 2009-12-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-02-01
First Submitted that Met QC Criteria 2009-12-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-02-05
First Posted (ACTUAL) 2009-12-04	Results First Posted N/A	Last Verified 2019-02

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:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Regimen 1 Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.	RADIATION: stereotactic body radiation therapy Given as a single fraction
EXPERIMENTAL: Regimen 2 Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Patients undergo a single fraction of SBRT between days 21-28 followed by pancreatoduodenectomy between days 35-63.	DRUG: gemcitabine hydrochloride Given IV RADIATION: stereotactic body radiation therapy Given as a single fraction

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Regimen 1

Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.

RADIATION: stereotactic body radiation therapy

Given as a single fraction

EXPERIMENTAL: Regimen 2

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Patients undergo a single fraction of SBRT between days 21-28 followed by pancreatoduodenectomy between days 35-63.

DRUG: gemcitabine hydrochloride

Given IV

RADIATION: stereotactic body radiation therapy

Given as a single fraction

Primary Outcome Measures	Measure Description	Time Frame
Preoperative treatment-related toxicity, defined as adverse events occurring prior to surgical resection
Postoperative surgical morbidity, defined as all other adverse events occurring within 90 days of surgery
Total dose of chemotherapy and radiotherapy delivered
Pre-treatment and post-treatment characteristics of the primary tumor on preoperative axial imaging including, but not limited to, tumor size, percentage of encasement/abutment of mesenteric vessels, and progression of disease
Postoperative complications including, but not limited to, need for reoperation, need for interventional radiology fluid collection drainage, systemic infection, wound infection, prolonged ICU stay, and delayed gastric emptying
Operative drain amylase at days 3 and 5 postoperatively
Length of hospital stay following pancreatic resection
Degree of histologic response of tumor in the resected specimen
Tumor samples for RNA and protein harvesting (when possible) from pretreatment biopsies and surgical specimens

Secondary Outcome Measures	Measure Description	Time Frame

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:

Pathologically confirmed localized adenocarcinoma of the pancreas or distal common bile duct

Pancreatic ductal adenocarcinoma or peripancreatic cholangiocarcinoma
Resectable disease, as determined by the Gastrointestinal Cancer Working Group disease-oriented team

Criteria used to define unresectability will include, but not be limited to, the following:

Tumor encases > 180 degrees of the circumference of the superior mesenteric artery
Tumor encases the common hepatic artery with no anatomic option for reconstruction following segmental resection
Superior mesenteric vein occluded or encased with no option for reconstruction following segmental resection
Soft tissue infiltration of the retroperitoneum to the left of the superior mesenteric artery
All malignant disease must be encompassed within a single radiotherapy field
No metastatic disease

Zubrod performance status 0-1
Absolute granulocyte count > 1,500/mm³
Platelet count > 100,000/mm³
Creatinine clearance > 50mL/min
AST and ALT < 5 times upper limit of normal
Serum bilirubin < 5 mg/dL (with biliary decompression)
INR ≤ 1.5
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Medically fit for pancreatic surgical resection, as determined by the investigating surgeons at the time of study enrollment
No evidence of an active second invasive malignancy outside the area of the pancreas or biliary system within the past 2 years, except for non-melanomatous skin cancer or carcinoma in situ of the breast, bladder, cervix, or uterus
No clinically significant cardiac disease, including the following:

Uncontrolled hypertension, defined as blood pressure > 160/90 mm Hg on medication
Myocardial infarction within the past 6 months
NYHA class II-IV congestive heart failure
Unstable symptomatic arrhythmia requiring medication (e.g., chronic atrial arrhythmia [atrial fibrillation or paroxysmal supraventricular tachycardia])

Atrial arrhythmia allowed provided it is well-controlled on stable medication
No current or recent (within the past 6 months) unstable angina
No recent (within the past 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, or clinically significant peripheral artery disease
No evidence of bleeding diathesis or coagulopathy
No significant traumatic injury within the past 28 days
No serious nonhealing wound, ulcer, or currently healing fracture
No AIDS
No significant infection or other coexisting medical condition that would preclude study therapy
No gastrointestinal fistula or perforation within the past 10 years

More than 2 years since prior chemotherapy (other than for pancreaticobiliary cancer)
More than 28 days since prior major surgical procedure or open biopsy
No prior intraabdominal radiotherapy in the planned field of pancreatic margin-intensive radiotherapy
No prior organ transplantation
No concurrent major surgical procedure
No other concurrent cytotoxic chemotherapy or anti-neoplastic biologic agents

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: John C. Mansour, MD, Simmons Cancer Center

Publications

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General Publications

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Clinical Trial Record